Company Job Listings

Job Title	Location
Director, Business Development - Medical Diagnostics This is an exciting position within a leading technology manufacturer developing a biological sensing platform for the medical diagnostics. The position is accountable for the execution of business development strategy to support the production of said products. You will be charged with overseeing the following activities: Shaping the product and technology roadmap and creating engagement strategies, while leading customer negotiations Assist in developing business development strategy Accountability for identification of sales prospects, development of customer relationships and close of sales opportunities Identifies business process improvement opportunities Represent the company at conferences and trade shows Ensure existing accounts are serviced effectively, obtain orders, and establish new accounts through organization and planning; implementing a tactical market plan Desired Skills: B.S with MBA Preferred 15+ years of experience business development/sales/marketing 10+ years of experience within the life sciences industry TWENTY	Boston, MA
Sr. Director Quality, CAR-T Manufacturing This is a stellar opportunity responsible for leading quality operational oversight and the development of strategic Quality Systems within a startup cGMP facility for CAR-T Cell Therapy clinical manufacturing within an established BioPharma organization. You will be charged with overseeing the following activities: * Overseeing and leading Quality systems and team members for Cell Therapy clinical manufacturing. * Developing, reviewing and approving validation and performance qualification protocols and reports, including investigations. * Supporting the review of documents such as batch records, methods and validation protocols/reports. * Participating in the investigation, assessment, and evaluation of quality records such as deviations, CAPAs, and change controls. * Supporting and driving continuous improvement initiatives of Quality Systems to ensure ongoing effectiveness, efficiency, and sustainability. * Monitoring Cell Therapy regulatory landscape to position the company for success and sustainability. * Training and mentoring team members on processes, regulations and guidelines. * Leading and developing new or emerging Quality opportunities in the external regulatory environment. * Maintaining GMP standards and requirements through review and approval of GMP documents (MBR/SOP). * Partnering with senior leadership to ensure delivery of an integrated approach to Cell Therapy Quality. Desired Skills: * 15+ years of Quality Systems or QA experience working on CAR-T Cell Therapy or Biologics manufacturing. Expertise in autologous or allogenic cell therapy manufacturing processes a plus. * BS or MS Degree in Biology, Chemistry, Pharmacy or related Life Sciences or Engineering field. * 3+ years of direct experience working on the process development or manufacturing of CAR-T Cell Therapy products. * CAR-T Cell Therapy Quality experience, including clinical lot release. * Quality Systems experience overseeing Deviations, CAPA, Change Control and GMP Document Management capabilities. * Experience ensuring cGMP compliance and knowledge of FDA regulations. * thirty About the Company: The position is within a top BioPharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity work in a major award winning Maryland based state-of-the-art large scale commercial biologics manufacturing facility. This site is a worldwide industry leader in mammalian cell culture manufacturing and has a promising pipeline of incoming Cell & Gene Therapies, mAb/recombinant protein and ADC therapeutic products.	Gaithersburg, MD
Quality Systems Manager, Cell & Gene Therapies This is a stellar opportunity leading quality oversight and the development of Quality Systems for Cell & Gene Therapy and CAR-T clinical manufacturing. You will be charged with overseeing the following activities: * Overseeing and leading Quality system setup for Cell & Gene Therapy and CAR-T clinical manufacturing. * Developing, reviewing and approving validation and performance qualification protocols and reports, including investigations. * Supporting the review of documents such as batch records, methods and validation protocols/reports. * Leading oversight of DS operational issues and shop-floor maintenance for DS area to ensure that the process conforms to the established standards. * Training and mentoring team members on processes, regulations and guidelines. * Maintaining GMP standards and requirements through review and approval of GMP documents (MBR/SOP). Desired Skills: * 5+ years of Quality Systems or QA experience working on Cell & Gene Therapy or CAR-T Process Development or manufacturing. * BS or MS in Chemistry, Biotechnology, Microbiology, Biology, related life sciences or engineering field. * Quality Systems Expertise implementing and managing Quality Management Systems (QMS). * Quality Systems experience overseeing Deviations, CAPA, Change Control and GMP Document Management capabilities. * Experience in Viral Vector, Cell & Gene Therapy (CG&T) or CAR-T drug substance/product manufacturing processes. * Experience ensuring cGMP compliance and knowledge of FDA regulations. * thirty About the Company: The position is within a top BioPharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity work in a major award winning Maryland based state-of-the-art large scale commercial biologics manufacturing facility. This site is a worldwide industry leader in mammalian cell culture manufacturing and has a promising pipeline of incoming Cell & Gene Therapies, mAb/recombinant protein and ADC therapeutic products.	Southern MD Facility, MD
Tetra Pak Process Engineer, Dairy Manufacturing You will be responsible for maintaining, troubleshooting, and repairing aseptic filling and packaging equipment and associated instrumentation and controls for an established and thriving East Coast dairy manufacturing company. This is an exciting opportunity to support the development and implementation of capital and continuous improvement projects within the aseptic operations scope. Your overall roles and responsibilities will include: * Diagnosing, repairing, mentoring, and training personnel to increase productivity and equipment capabilities on aseptic equipment. * Troubleshooting and maintaining electrical control systems, electromechanical equipment, and related instrumentation. * Defining, scheduling, and performing maintenance tasks to promote optimal equipment performance. * Identifying and developing logical and visual programming changes, escalating for validation and implementation when necessary. * Developing working drawings for parts and assemblies using CAD software as required for repairs and improvements. * Supporting the sizing and specification of equipment and process changes to align with conventions and requirements. * Complying with GMPs, SOPs, corporate and plant policies, rules, and regulations. * Ensuring corporate policies and followed in capital project implementation up to and including contractor compliance. * Aiding and supporting areas in the production facility as assigned, as well as training and building competence on key areas in production. * Reporting food safety problems and initiating action for supporting SQF by maintaining food safety and quality. * Assisting engineering, plant maintenance, and other functional groups in resolution of issues, development/implementation of improvement projects, and development of training needs/opportunities. Desired Skills: * Bachelor?s or equivalent education, certification, and experience. Engineering or POM is required. * 5+ years of experience working with Tetra Pak equipment. * 2+ years of experience installing aseptic dairy processing and/or filling equipment. * 3+ years of experience leading maintenance of aseptic dairy production equipment in a 24/7 environment. * Engineering technical expertise working with beverage and food processing equipment including blending systems, mixing tanks, steam injectors, liquid processing tanks, Tetra Pak fillers, conveyors, and palletizers. * Process Improvement experience implementing Six Sigma methodologies involving Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus. * Engineering expertise programming and troubleshooting manufacturing process automation systems systems including PLC and DLC based Rockwell and Wonderware automation systems. * Expertise working within cGMP, FDA, SQF, USDA, HACCP & OSHA compliance and providing appropriate engineering documentation & SOPs. * Lean Six Sigma Black Belt, Master Black Belt Certification or PMP Certification a plus. About the Company: This is an exciting new position within a top-tier East Coast based Dairy Company focused on delivering quality, long-lasting, aseptic products to its customers.	Syracuse, NY
Lead Facilities Utilities Engineer, Dairy Manufacturing You will be responsible for providing judgement and expertise related to utilities and physical infrastructure supporting production processes for an established and thriving East Coast dairy manufacturing company. This is an exciting opportunity to support the development and implementation of capital and continuous improvement projects within the aseptic operations scope. Your overall roles and responsibilities will include: * Diagnosing, repairing, mentoring, and training personnel to increase productivity and equipment capabilities on aseptic equipment. * Troubleshooting and maintaining production process utility systems and related controls. * Design, implement, and execute process data collections and analysis. * Identifying and developing physical and software changes to systems and equipment to ensure reliability and performance are at maximum. * Overseeing maintenance activities and care of buildings and property grounds. * Maintaining well-organized documentation of proposed and approved changes, trial and production configurations, maintenance activities, performance/quality reporting, and related communications. * Complying with GMPs, SOPs, corporate and plant policies, rules, and regulations. * Conducting training and administering corrective actions as required. * Maintaining quality relationships with customers, external vendors, and within the organization. * Enforcing Good Manufacturing Practices and ensuring adherence to Corporate and/or Plant Policies, rules, and regulations. * Ensuring and inspecting compliance with legal requirements regarding dairy processing, safety, and working conditions department and organization wide. * Supporting SQF compliance by setting high standards for food safety and food quality. Desired Skills: * Minimum of GED or High School Diploma is required. * 5-7+ years of experience working in industrial utilities. * 3-5+ years of experience in industrial automation highly desired. * Prior experience working for a multi-site manufacturing environment is preferred. * Ability to adjust to changing circumstances and meet deadlines outlined by the company. * Working knowledge of Good Manufacturing Practices. * Advanced mechanical and troubleshooting skills. * Proficient in Microsoft Word, Outlook, and Excel. About the Company: This is an exciting new position within a top-tier East Coast based Dairy Company focused on delivering quality, long-lasting, aseptic products to its customers.	East Syracuse, NY
Lead Process Engineer, Dairy Foods Manufacturing This is a stellar opportunity within an established and thriving east coast based dairy company. You will serve as a technical leader overseeing batching, receiving, pasteurization, and storage processes for fluid milk and other raw ingredients. In this role, you will lead design and execution of capital and operational improvements to maximize efficiency and productivity. Your responsibilities will also include: * Leading Process Development activities for Aseptic Manufacturing for fluid dairy and ESL dairy products. * Troubleshooting and maintaining electrical control systems, electromechanics equipment, and related instrumentation and controls. * Identifying, developing, and executing logical and visual programming changes to SCADA systems and equipment. * Mentoring and training employees in duties and skills of this role as necessary. * Supporting lifecycle of change and configuration for equipment and processes. * Generating and maintaining comprehensive documentation of changes, configurations, maintenance activities, performance/quality reports, and related communications in well-organized repositories. * Developing and presenting potential changes to lower risk, increase benefits, and leverage resources to improve performance. * Establish and maintain relationships with customers, external vendors, and within the organization. * Leading and supporting development of capital project planning and support strategic capital planning processes. * Acting as SME within the industry for dairy and ESL dairy equipment, processes, and innovation to support initiatives. * Ensuring GMPs and strict adherence to Corporate and Plant Policies, rules, and regulations. Desired Skills: * Bachelors Engineering degree a plus. High School Diploma or GED required. Additional dairy processing education and/or experience strongly preferred. * 5+ years experience working within an FDA or GMP regulated dairy, fluid food production, pharmaceutical or complex food manufacturing environment. * Experience with PLCs, machine HMIs, motor/servo drives, process instrumentation (proximity, temperature, level, conductivity, pressure) strongly preferred. * Previous experience working in a dairy or complex food manufacturing environment with industrial utilities preferred. * Advanced electrical and electromechanical troubleshooting skills. * Experience in technical writing, process and quality control documentation, and technical presentations. * Automation Systems experience programming, troubleshooting, and maintaining Allen Bradley PLC, Rockwell/RSLogix/FactoryTalk, Wonderware, Ignition, and similar software. About the Company: This is an exciting new position within a top-tier East Coast based Dairy Company focused on delivering quality, long-lasting, aseptic products to its customers.	Syracuse, NY
Sr. Process Validation Engineer This is an excellent opportunity with a global, high-growth company. The role would require participation in validation projects related to Process Performance Qualification (PPQs), control strategy development, mixing and hold studies, manufacturing processes, and new component and equipment validation. Additional responsibilities would include: * Supporting the Equipment, Process and Cleaning Validation Team throughout the facility. * Coordinating multiple projects, documenting activities, and creating summary report templates. * Performing Qualification activities such as controlled temperature units, CIP, SIP, Lyophilizers, Autoclaves, parts washers, and terminal sterilizers. * Supporting customer product launches. * Establishing new templates, validation strategies, and policies. * Supporting capital expansion projects such as formulation suites, filling lines, and packaging equipment. * Reviewing facility changes and providing input on re-validation. * Performing risk assessments in processing steps and related to equipment. * Developing and reviewing validation requirements and design deliverables. * Partnering with contract validation teams to support and monitor efforts. * Monitoring validation strategies, ensuring policies are followed, conducting validation studies in accordance with batch records and protocols. * Identifying exceptions associated with validation protocol execution. Desired Skills: Minimum Requirements: * Bachelor?s degree in Science, Technology, Engineering or Mathematics. * 5-8+ years of experience in Validation or a related field. * Previous GMP experience or other regulated industry preferred. * Competent in at-risk mitigation for function. * Previous customer facing experience. * Able to communicate effectively, verbally and in writing. * Self-motivated and action oriented. * thirty About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site.	Bloomington, IN
Sr. Director, Facilities & Engineering, BioPharma Manufacturing This is an exciting opportunity to lead the department comprising of Facilities Maintenance, Metrology, Clean Utility, Project Engineering, and Automation teams. The ideal candidate would be responsible for ensuring compliance and driving continuous improvement. Additional responsibilities would include: * Assuming accountability for management of building, equipment, and grounds. * Maintaining relevant files, drawings, and records required for GMP operation. * Recruiting, developing, and retaining talent to deliver business goals. * Managing projects, capital and non-capital, to improve capacity, quality, efficiency, utilization, and EHS. * Developing and forecasting 5-year capital plan as well as department budget. * Maximizing output, minimizing cost, supporting efficiencies, and improving EHS performance for projects. * Consulting and maintaining effective communications and working relationships with authorized and required groups. * Maintaining relevant knowledge of governing cGMP regulations, city requirements, state and federal permitting, and environmental agencies to best manage programs. * Ensuring Planned Maintenance and calibrations are within compliance. * Maintaining up-to-date Computerized Maintenance Management Systems (CMMS). * Collaborating with Manufacturing and Quality departments to ensure equipment and facilities remain available for use and does not impact ability to deliver projects and products. * Taking ownership of asset readiness as part of the NPI process. * Serving as a member of the Site Team Leadership Team and demonstrate ownership of Business Unit Goals and Objectives. * Serving as the primary source of emerging trends in compliance, anticipating impacts on process, and working with stakeholders to determine how to address them. Desired Skills: Minimum Requirements: * Bachelor?s degree and 10+ years of experience in industrial maintenance involving mechanical, electrical, and electronics in a cGMP environment is required. * Extensive experience with capital expenditure and project related work. * Working knowledge of automation control, alert, and data collection systems. * Working knowledge of HVAC and clean utility systems. * Able to communicate effectively, verbally and in writing. * Understanding of financial concepts that impact capital investments and business EBITDA. * Excellent management, prioritization, and problem-solving skills a must. * Ability to interpret and analyze data, information, and documents. * Knowledge of FDA healthcare compliance rules and regulations. * thirty About the Company: This opportunity is within an established industry leading Contract Research and Contract Manufacturing organization. The position and company offers exceptional career growth and stability due to a steady stream of new pipeline products and projects. This is a full time position working on site.	Baltimore, MD
Associate Director, GMP Quality Assurance null About the Company: This is an exciting position with a leading US biologics contract testing, development and manufacturing organization. It's also an opportunity to work with leading BioPharma companies and contribute to the successful development of a promising pipeline of therapeutics.	Worcester, MA
Beer Consultant null About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches.	Buffalo, NY
2023 Branding and Marketing Leader null About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches.	Buffalo, NY
Sr Scientist, Fermentation This is an exciting scientific opportunity within an ultra-innovative food & nutritional products company. You will be charged with driving and applying microbial fermentation and biotransformation efforts for the development of novel category defining plant-based food & beverage, functional foods and nutritional products. Your overall roles and responsibilities will include: - Designing and leading experiments and process development efforts involving microbial fermentation and biotransformation. - Leading strain improvement and fermentation optimization experiments. - Leading and designing fermentation scale-up processes and from bench scale to pilot scale through to commercialization. - Partnering with flavor creation and application teams to ensure successful development of new flavors and tastes. - Collaborating with cross-functional teams on projects including process optimization, analytical characterization. - Ensuring current knowledge of food ingredient and alternative trends for the future identification of strategic product development opportunities. Desired Skills: - MS or Ph.D. in Microbiology, Biology, Biochemistry, Protein Chemistry, Molecular Biology or related life science field. - 3+ years of successful food ingredient, or food grade protein development, innovation and commercialization experience. - Expertise in microbial fermentation, strain improvement, enzymatic assays and protein purification efforts. - Expertise performing microbial, bacterial or yeast fermentation processes a plus. - Lab and pilot scale expertise operating fermenters or bioreactors. - Analytical development expertise characterizing proteins utilizing SDS-PAGE, Western Blots, Enzyme Activity Assays, HPLC and Carbohydrate Chemistry techniques. - Scientific lab expertise working with proteins, nutritional ingredients, lipids, vitamins, nutritional food components, or sensory science a plus. * thirty About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches.	Buffalo, NY
Chief Operations Officer, Complex Food Sciences and Manufacturing This is a unique C-Level leadership growth opportunity within the US?s largest low acid aseptic beverage Research, Development and Manufacturing operation. You will oversee company operations including major manufacturing partnerships with the world's largest and prestigious food & beverage companies. Company operations also include an emerging portfolio of plant-based branded products. This is a unique opportunity to lead highly technical low acid aseptic Development and Manufacturing Operations with recent plant capital improvements and a new R&D Innovation Center. You will be charged with overseeing the following activities: * Directing the strategy of a 600+ person company to ensure the attainment of revenue and profit goals with responsibility for profit & loss and the achievement of current and long-range objectives. * Driving site operational effectiveness through a passion for excellence, investment in customer success, delivery of innovative manufacturing solutions and collaboration among departments. * Developing the vision and direction of the low acid aseptic beverage manufacturing and operational strategy in conjunction with the company's long-term vision. * Overseeing the management of all areas of business operations including Manufacturing, Supply Chain, Quality, Engineering and R&D Innovation Center producing company owned Elmhurst branded products and customers? products manufactured on-schedule within quality standards and cost objectives. * Working alongside Business Development, Sales and Marketing teams to ensure continuation and growth of revenue generation through selling of branded products, R&D, Scientific Development and Manufacturing capabilities for the manufacturing and packaging operations. * Developing and implementing strategic supply chain plans and cold chain processes supporting low acid aseptic manufacturing operations. * Directing the scheduling of manufacturing operations and key manufacturing personnel while working within cGMP, HACCP and ISO compliance and meeting quality standards. * Coaching, mentoring, and managing manufacturing and Quality teams/staff through a Shared Leadership initiative and by establishing performance standards, evaluation of performance, employee recognition and determining employee responsibilities. * Driving the reduction of Cost of Goods through budgetary, financial and logistical management while ensuring the highest level of Quality and Regulatory Compliance. * Driving the success of 9 figure company owned real estate properties furthering the development of leasing and development partnerships. Desired Skills: * MS or Ph.D. in Food Science, Biology, Chemistry, Microbiology, Chemical Engineering or related Scientific/Engineering field. MBA Preferred. * 15-20+ years of successful GMP regulated Pharmaceutical, Biotechnology or low acid aseptic foods operations and manufacturing leadership experience. * Entrepreneurial, visionary and strategic team leadership experience with the ability to work within a dynamic fast paced ultra innovative team environment. * Exceptional Business Operations and Financial Management expertise with demonstrated P&L oversight, forecasting, budgeting and accounting experiences. * Excellent demonstrated technical skills to understand low acid aseptic beverage or pharmaceutical manufacturing processes, including knowledge of microbiology, biotechnology and biochemistry principles. * Operations leadership experience overseeing corporate real estate development projects, plant expansions, manufacturing capacity improvements, and supply chain operations. * Lean Manufacturing, Continuous Improvement and Lean Manufacturing expertise. * Experience working within FDA, GMP, HACCP and ISO compliance. * Please note, this is a key leadership position based at a major manufacturing plant and R&D site. Living and working in Buffalo is an absolute requirement for this position. * About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches.	Buffalo, NY
Environment, Health & Safety Staff Specialist, Cell Therapies Manufacturing This is a stellar opportunity to serve as an EHS Staff Specialist within an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies. The qualified individual would be required provide technical leadership to ensure the biological safety programs adhere to federal, state, and local EHS regulations. Your responsibilities would also include: * Completing hazard assessments, IH monitoring, process hazard analysis, life safety reviews, incident investigations, environmental regulatory field analysis, environmental reports, and permit application. * Reviewing processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines. * Providing support in completing injury and illness analysis, training, self-assessments and addressing specific EHS concerns. * Performing area inspections for compliance including periodic documentation review. * Leading the Safety Committee in developing EHS self-assessment program and standards implementation tracking. * Participating in regulatory inspections and assisting in addressing noted concerns and citations. * Serving as the primary system admin for the EHS system including technical and functional support for users. * Managing user security, permissions, and location scope. * Reviewing data for quality and timeliness, and identifying all data gaps, outliers, and other concerns with users. * Generating procedures and training documentation for users. * Assisting teams with adding tasks, audits, and system changes. * Generating output reports and dashboards using the appropriate BI tools; tracking and communicating EHS score card metrics to team members. Desired Skills: * Bachelor?s degree with a concentration in safety, microbiology, environmental health, public health, chemical engineering, or a related technical field. * 5+ years of BioPharma or Biotechnnology experience working on cell therapies, gene therapies, biologics, large molecule or vaccine GMP manufacturing operations. * Knowledge of biological agents and recombinant DNA in research and manufacturing setting. * Expertise in Biosafety Level 1 and 2 (BSL-1 and BSL-2) containment and practices. * Working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, OSHA BBP, and other regulations and consensus standards required. * RBP, CBSP, CIH, and/or CSP certification is preferred. * Ability to work in a fast-paced, collaborative environment and manage multiple projects with a high degree of independence. About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.	Philadelphia, PA
Sr. Recruiter, Food and Beverage Products We are seeking a Senior Recruiter to join our team and work on filling Executive and leadership positions for innovative plant-based food and beverage products. You will be responsible for recruiting Scientists, Operations, Marketing and Sales leaders and interfacing regularly with client companies. Responsibilities: - Work closely with established client companies to understand their hiring needs and develop recruiting strategies to identify and attract top talent in the plant-based food and beverage industry. - Recruit and network among Food and Beverage, plant-based foods, organic foods and natural products company and industry contacts. - Use our state-of-the-art web-based applicant tracking system (ATS) to post job openings, score and rank incoming candidates, submit candidates and search our large candidate database to quickly identify the right candidates for each job requirement. - Develop and implement unique online candidate sourcing strategies working with email correspondence, LinkedIn, and other online search tools. - Negotiate with candidates and clients to secure offers and agreements while maintaining strong professionalism and high ethics. Desired Skills: - Proven experience as a Recruiter with expertise and success filling technical, scientific and operational positions within the Food and Beverage, plant-based foods, organic foods, natural products, nutritional products or Life Sciences industries. - Prior manufacturing, Sales, R&D, Scientific or Engineering experience working within a plant-based food, food and beverage products or natural products company preferred. - Excellent online skills including experience with email correspondence, LinkedIn, and online search tools. - Creative ability to develop and implement unique candidate sourcing and recruiting strategies. - Exceptional negotiation skills, with the ability to maintain strong professionalism and high ethics while working with candidates and clients. - Knowledge and industry expertise within the plant-based food and beverage products and the Natural Products marketplace. Past experience attending Natural Products Expo West or Expo East conferences a plus. - This position can be virtual or based in our Aliso Viejo, CA office. About the Company: Laguna Source is a specialty search firm placing Engineering, Scientific and Quality leaders and professionals within the Biotechnology, BioPharmaceutical and Food & Nutrition industries. We recruit Scientists, Engineers, Directors and Managers within the fields of Molecular Biology, Protein Engineering, Biologics Manufacturing, Process Development, Upstream Cell Culture, Downstream Protein Purification, Pharmacology, Clinical Development, Data Management, Immunology, Oncology, Computational Chemistry, Bioinformatics, Biostatistics, Biochemistry, Quality Assurance, Quality Control and Regulatory Affairs.	Aliso Viejo, CA
Associate Director, Quality Control (QC) Microbiology / Environmental Monitoring This is an exciting opportunity to lead the Quality Control Microbiology and Environmental Monitoring team. The qualified individual would be responsible for the Operational business of the QC Microbiology sterility testing team and the oversight of the Environmental Monitoring (EM) program. Additional responsibilities would include: * Representing the site in client interactions for all questions related to Microbiology testing or the Environmental Monitoring program. * Representing the site in audits and inspections related to Microbiology testing or Environmental Monitoring program. * Supervising Microbiology assay and EM teams, acting as an advisor to team members when determining how to meet schedules or resolve technical problems. * Reviewing testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures. * Developing site Environmental and Utility monitoring programs and policies, ensuring sampling plans are up to date and executed as planned. * Hosting monthly trend meetings, sharing trend information with the site Quality Council, and identifying and escalating adverse trends. * Driving corrective and preventative actions, ensuring work is complete and the site remains in a state of control and compliance. * Leading environmental excursion investigations. * Monitoring QC resource capacity and providing feedback to QC management, program management, and production planners when capacity constraints exist. * Leading, mentoring, and coaching staff. * Preparing responses to audits, deviations, out of specification, customer complaints, and corrective and preventative actions (CAPA). * Preparing monthly management reports including budget analysis and project updates. Desired Skills: Minimum Requirements: * BS in related scientific field, advanced degree preferred. * Advanced skills and experience in QC. * Experienced hands-on knowledge in management or leadership role. * Proven experience developing budgets, monitoring, and escalating variances. * In-depth understanding of concepts and principles in own discipline and basic knowledge of how these elements apply in other areas. * Working knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required. * Maintains up to date knowledge of new technologies and potential applications. * Knowledge of how to execute team methods/procedures and operate equipment, and ability to support analyst tasks on a non-routine basis. * Knowledge of SAP and TrackWise systems a plus. * Ability to use experience to problem solve, make decisions, and make plans to improve departmental strategies. * thirty About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19.	Houston, TX
Tax Manager null About the Company: The company is a biological CDMO (Contract Development Manufacturing Organization) company that provides a high level of manufacturing services from clinical to commercial products. They aim to become a Global Top 10 CDMO company in the biopharmaceutical industry, and their highest priority is to advance the quality of health of their end customers, their patients. By improving the health of the users of their products, they aim to improve lives on a global scale and contribute to making a positive impact on the world.	Syracuse, NY
Project Manager, BioPharma Manufacturing This is an exciting new opportunity to work within an expanding Biologics Contract Manufacturing Organization with major growth efforts due to new client acquisitions and facility expansion projects. You will be responsible for managing leadership of priority site and customer-based projects. Additional responsibilities of this role will include the following: * Managing project teams and working with key partners to ensure project deliverables are met. * Gathering and organizing requirements of customers and stakeholders into a project plan. * Leading Site and Customer based projects as project manager, including but not limited to spearheading efforts, capital projects, tech transfer, campaign preparedness, and productivity improvements. * Defining project teams and project management resource requirements. * Leading kickoff meetings, recurring status meetings, reporting, risk tracking, committee meetings, and conflict resolution. * Developing and driving detailed plans, identifying critical path and timing while meeting strategic intent and achieving key milestones. * Identifying, documenting, resolving, communicating or escalating major risks to senior leadership when appropriate. * Managing expectations by collaborating with key stakeholders. * Driving consistency in project management tools and templates in line with PMO best practices and project management fundamentals while being mindful of safety, quality, scheduling, and budgets. * Developing project and site metrics, dashboards, and reports. * Fostering inclusive teams and maintaining strong relationships with operational, functional, and customer leadership teams. Desired Skills: * Bachelor?s degree required. BS, in Engineering, Science, or technical discipline. * PMP certification desirable. * 4+ years of experience in a Project Management position. * Knowledge and understanding of cGMPs and familiarity with manufacturing processes. * Experience in pharmaceuticals, laboratory, manufacturing, utilities and infrastructure, construction, maintenance, and/or operations preferred. * Strong analytical, data aggregation and analysis, communication, and presentation skills. * Demonstrated experience managing to deliverables and milestones on time and within budget while meeting business and stakeholder needs. * Experience leading projects for drug manufacturing sites. THIRTY About the Company:* The company is a biological CDMO (Contract Development Manufacturing Organization) company that provides a high level of manufacturing services from clinical to commercial products. They aim to become a Global Top 10 CDMO company in the biopharmaceutical industry, and their highest priority is to advance the quality of health of their end customers, their patients. By improving the health of the users of their products, they aim to improve lives on a global scale and contribute to making a positive impact on the world.	Syracuse, NY
Paralegal, EHS BioPharma Manufacturing This is an exciting new opportunity to work as a Paralegal within an expanding Biologics Contract Manufacturing Organization with major growth efforts due to new client acquisitions and facility expansion projects. You will be responsible for handling and coordinating legal programs within a large US Site headquarters and manufacturing site. The responsibilities of this role would include the following: * Serving as primary point of contact and interface with external Council. * Identify and manage outsourced counsel to address site needs including Employment Law, Environment, Safety, Contracts, Taxation and General Counsel. * Conduct initial and final review of legal documents in collaboration outsourced counsel. * Assist in drafting, reviewing, checking, and organizing legal documents prepared by outsourced such as contracts and intercompany agreements. * Designing and managing document libraries and managing permissions on sites. * Assist with SOX compliance matters and review of statutory accounts. * Managing the preparation and distribution of EOHSS/EHS communications. Desired Skills: * Bachelor?s degree with Paralegal certificate or related qualification. * 5+ years of paralegal experience within a law firm or the legal department of a large multinational corporation. * Experience working within a BioPharma, Pharmaceutical, Biotechnology or Manufacturing environment preferred. * Merger and acquisition and business development transactions experience a plus. * thirty About the Company: The company is a biological CDMO (Contract Development Manufacturing Organization) company that provides a high level of manufacturing services from clinical to commercial products. They aim to become a Global Top 10 CDMO company in the biopharmaceutical industry, and their highest priority is to advance the quality of health of their end customers, their patients. By improving the health of the users of their products, they aim to improve lives on a global scale and contribute to making a positive impact on the world.	Syracuse, NY
Human Resources Senior Manager, BioPharma Manufacturing This is an exciting new opportunity to work within an expanding Biologics Contract Manufacturing Organization with major growth efforts due to new client acquisitions and facility expansion projects. The responsibilities of this role would include the following: * Serving as a strategic HR leader for the startup of a new Global Biologics CDMO. * Overseeing the completion and management of compensation and benefits documentation. * Serving as the first point of contact for all HR-related inquiries. * Managing HR department activities, including compensation, benefits, performance management, talent acquisition, and HR strategy. * Directing training, on-boarding, employee engagement activities, and relevant tasks. * Understanding and incorporating UKG software and CDMO industry practices. Desired Skills: * Bachelors degree in related discipline required. * 10+ years of experience in HR role is required. * Expert knowledge of HR, talent management, employee relations, compensation, benefits, talent acquisition, and professional development. * Well versed in current labor laws to ensure compliance. * Experience working with HR Managements systems including UKG software. * Knowledge or work experience within the BioPharma, Biotechnology, CDMO or CMO Biologics manufacturing industry a plus. About the Company: The company is a biological CDMO (Contract Development Manufacturing Organization) company that provides a high level of manufacturing services from clinical to commercial products. They aim to become a Global Top 10 CDMO company in the biopharmaceutical industry, and their highest priority is to advance the quality of health of their end customers, their patients. By improving the health of the users of their products, they aim to improve lives on a global scale and contribute to making a positive impact on the world.	Syracuse, NY
Reliability Manager, Complex Foods Manufacturing This is a unique opportunity responsible for leading a small team and driving site wide Reliability Engineering initiatives for the manufacturing of complex food products. It's an outstanding opportunity responsible for leading and championing Reliability Centered Maintenance, Reliability Strategies and Predictive Maintenance programs to harmonize site-wide manufacturing. You will also be responsible for: * Leading team members responsible for championing Reliability Centered Maintenance, Reliability Strategies and Predictive Maintenance programs for manufacturing equipment, site facilities and utilities. * Utilizing key reliability tools including RCA, PdM and FMEA to champion cost reductions and manufacturing improvements. * Managing predictive technologies including Vibration Analysis, Thermal Analysis, Ultrasound Analysis, Infrared Analysis and Oil Analysis to increase equipment uptime. * Developing creative solutions to achieve the highest metrics for increasing equipment uptime availabilities, performance capacities, and OEE Overall Equipment Effectiveness. * Tracking major equipment downtime and developing plans for enhanced performance. * Developing plans to implement global TPM (Total Productive Maintenance) pillars involving preventative maintenance, periodic maintenance, corrective maintenance, and maintenance prevention activities to achieve zero defects, zero breakdown, and zero accidents in all functional areas of the organization. * Utilizing continuous improvement, TPM, Total Quality Management, Six Sigma methodologies, and Lean Manufacturing techniques to develop a best-in-class maintenance program. * Supporting capital projects and process improvements involving high volume packaging systems and food production equipment including blending systems, mixing tanks, steam injectors, spray dryers, and liquid processing tanks. * Serving in a Project Leadership role managing complex, strategic cross-functional projects for delivering Reliability Excellence across a rapidly growing complex food manufacturing site. Desired Skills: * BS or MS degree in Mechanical Engineering, Electrical Engineering, Biochemical Engineering, Chemical Engineering or related Engineering field. * CMRP (Certified Maintenance & Reliability Professional) certification highly desired * 5+ years of experience leading and championing Reliability Centered Maintenance, Reliability Engineering or Maintenance Engineering related initiatives and programs. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Expertise and knowledge of vibration analysis, infrared thermography, oil analysis, non-destructive testing, and material chemical compatibility. * Experience implementing TPM Maintenance Systems, TPM Pillars, and Maintenance master plans. * Food & Beverage, Dairy Foods, Dairy Spray Dry or Nutritional Foods manufacturing expertise working within cGMP, FDA, HACCP & OSHA compliance. * Lean Six Sigma Green Belt, Black Belt or Master Black Belt Certification a plus. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Grand Rapids, MI
Manager, Global Sensory Sciences, Nutritional Products This is a stellar opportunity responsible for leading Global Sensory Science teams within an established and growing Midwest based complex nutritional foods market leader. You will be responsible for the strategic delivery of sensorial and consumer product research to drive innovation and development. Your responsibilities will also include: * Leading a Global Sensory Science team in support of major Nutritional products to deliver growth strategies, provide consumer foresights and insights, develop a suite of best-in-class consumer methodologies, provide analysis of data, and deliver holistic recommendations to drive business impact. * Leading Sensory best practices for delivering taste, texture, flavor, mouthfeel and aroma preferences to ensure effective product design. * Strategically lead Consumer Learning Plans in partnership with Key Product development, Insights and Analytics, and Marketing stakeholders. * Identifying new and relevant sensory and consumer science insight. * Upskilling the sensory and consumer science team through execution of new methods and tools, including adopting new practices incubated by the New Practices team. * Continuous and strategic resource and project planning, prioritization and execution of team research programs to drive business impact. * Ensuring all product research meets legal, regulatory, and safety requirements. * Management of direct reports, training, and team engagement to build one cohesive team. * Implementation of new research techniques into the business. * Serving as expert within sensorial and consumer science, specializing in Nutrition business focused on Latin America, Asia, and the US. Desired Skills: * MS or Ph.D. in Nutrition or a related field and relevant industry experience. * 5+ years of proven Sensory Science or consumer science experience. * Sensory science working experience within a major Beverage, Dairy Foods, Nutritional Products or Infant Formula where consumer research is a key deliverable. * Sensory science working experience relating to pediatric, children?s or infant aged products a plus. * Expertise leading Sensory science best practices for delivering taste, texture, flavor, mouthfeel and aroma preferences. * Managerial and leadership experience overseeing Sensory Science or related Scientific teams. * Ability to identify and integrate sensory and consumer methods into research plans, integrate data, and draw conclusions. * Able to work in collaboration with and foster new internal and Global external partners. * Must be a motivated, open-minded, curious, entrepreneurial, and ambitious leader. * Language proficiency in Spanish or Mandarin preferred. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Evansville, IN
Automation Engineer, Nutritional Foods Manufacturing This is a stellar opportunity within an established, thriving and growing Midwest based complex nutritional foods market leader. You will be responsible for performing the maintenance, troubleshooting, and upgrades for the plant networks, automation, and manufacturing systems including Rockwell, Allen-Bradley and DeltaV automation systems. Your responsibilities will also include: * Serving as a technical lead on projects to upgrade and implement PLC based control systems including Rockwell, Allen-Bradley and DeltaV automation systems for processing and packaging of consumer products. * Serving as a technical lead on projects to update network hardware for virtualized Automation Systems including Rockwell Automation software. * Serving as a technical lead on new site historian, batch and OEE reporting solutions. * Project development, maintenance, and troubleshooting of industrial and computer networks including virtualization hardware and platforms (VMWare and/or Hyper-V), Microsoft SQL Server or Active Directory domain services management. * Working with reporting solutions including Microsoft SQL/SSRS, FactoryTalk VantagePoint, Crystal Reports or Power BI. * Leading CSV (Computer Systems Validation) activities. Desired Skills: * Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * Automation Systems expertise with PLC based control systems including Rockwell, Allen-Bradley or DeltaV automation systems. * Food Processing, Nutritional Foods, Pharmaceutical or Regulated Consumer Products industry experience working within FDA, HACCP or cGMP compliance a plus. * Experience with virtualization hardware and platforms including VMWare vSphere/vCenter, Microsoft Hyper-V, Dell PowerEdge, Dell VRTX, Microsoft SQL Server or Active Directory domain services. * Experience working with reporting solutions including Microsoft SQL/SSRS, FactoryTalk VantagePoint, Crystal Reports or Power BI. * Computer Systems Validation (CSV) experience. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Grand Rapids, MI
Engineering Manager, Nutritional Foods Manufacturing This is a stellar Engineering leadership opportunity within a thriving, growing and tier 1 Midwest based complex food production company! You will be responsible for leading all plant-wide site engineering and maintenance activities for the successful manufacturing of brand name complex food products within a high volume processing and packaging environment. Your hands on responsibilities will also include: * Leading an Engineering and Maintenance organization consisting of Maintenance, Automation Engineering, Reliability Engineering, Utilities Engineering, Project Engineering, HVAC Engineering, and Waste Water Treatment teams. * Overseeing Facilities, Utilities, Site Grounds, Waste Treatment, Power Systems, HVAC, Automation Systems and Steam Systems. * Utilizing modern TPM, Total Quality Management, Six Sigma methodologies, and Lean Manufacturing techniques to develop a best in class maintenance operation. * Developing and implementing strategic operating plans to ensure the highest standards of safety, quality, reliability, cost control, and regulatory compliance. * Managing Maintenance Department budgets, capital budgets, and project budgets. * Supporting capital projects and process improvements involving high volume packaging systems and food production equipment including blending systems, mixing tanks, steam injectors, spray dryers, and liquid processing tanks. * Ensuring compliance with cGMP, OSHA, HACCP and EHS regulations. * Leading equipment, facilities, utilities, and shop floor troubleshooting activities. Desired Skills: * BS or MS degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering or related Engineering field. * 10+ years of Food Processing and Packaging experience. * Maintenance and Engineering departmental management and leadership experience overseeing Manager, Supervisor and Staff level employees. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * Engineering expertise supporting Manufacturing Equipment, Utilities, Facilities, Site Grounds, Waste Treatment, Power Systems, HVAC, and Steam Systems. * Expertise working with manufacturing facility Automation Systems including DeltaV DCS and Allen Bradley PLC systems. * Process Improvement experience implementing TPM, Total Quality Management, Six Sigma methodologies, and Lean Manufacturing techniques including Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus. * Expertise working within cGMP, FDA, HACCP & OSHA compliance and providing appropriate documentation & SOPs. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Evansville, IN
Maintenance Manager, Complex Food Manufacturing This is a stellar opportunity within an established, thriving, and growing Midwest based complex nutritional foods market leader. You will be responsible for managing the maintenance services to enable operations and other functions to meet or exceed business expectations. Your responsibilities will also include: * Developing and communicating a clear vision for a fully integrated Maintenance team aligned with company goals. * Providing leadership through the identification and introduction of innovative solutions. * Driving continuous improvement, exploring industry trends, developing strategies, and driving leading edge technology and innovation. * Establishing capital spending strategies to effectively identify and invest in company assets. * Understanding the procurement polices and working cross functionally to ensure compliance with internal policies and procedures. * Developing staff and building a high-performance team by setting expectations, ensuring ongoing coaching/mentoring, and assessing employee performance. * Leading projects and teams supporting large scale company initiatives. * Building technical competencies within the maintenance team, identifying, and selecting maintenance talent to support developing technology, and providing opportunities for knowledge acquisition and skills transfer within the team. Desired Skills: * Bachelor?s degree in engineering or a related field. MBA or other advanced degree preferred. * 7-10+ years in Plant Maintenance roles supporting manufacturing and/or utility operations. * Experience managing or leading maintenance teams including reliability centered programs. * Experience managing people in a dynamic environment and a track record of developing people. * Experience within a highly regulated environment. * Proven decision-making skills, strong troubleshooting, planning, prioritization, multi-tasking, and delegation skills. * Ability to communicate issues, goals, and objectives to facilitate an effective team-oriented environment. * Demonstrated ability to work with a range of technically and culturally diverse people, delivering value added business results that meet high quality * Significant experience in powder and liquid processing and packaging of food products, preferably within a highly regulated food or pharmaceutical environment. * Knowledge of engineering and maintenance concepts and industry technology. * Understanding of manufacturing processes and mastery knowledge of utility sustainability, power supply and demand. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Grand Rapids, MI
Utilities Planner/Scheduler, Complex Foods Manufacturing This is a unique opportunity responsible for facilitating and communicating planned maintenance activities for facilities and utilities supporting the manufacturing of Food and Nutritional products. You will also be responsible for: * Developing and implementing preventative, corrective, and shutdown related job plans for all utilities systems including Refrigeration, Compressed Air, Steam Generation, Process Water, and Electrical distribution systems. * Develops equipment lists, design criteria codes, enters new equipment into computer information system, to better utilize the information into CMMS system. * Utilizing CMMS SAP Maintenance System CMMS for the purpose of tracking equipment history, labor & material spending, and all maintenance activities related to the facility and production equipment. * Facilitates and communicates planned maintenance activities with production / crafts from shift to shift * Coordinates the planning and scheduling of external contractor work to support Manufacturing * Manage outages and maintenance projects, long term maintenance planning for future outages, including corrective maintenance work * Provides technical assistance and/or resources to address maintenance issues as required * Completes timely follow-up of planned maintenance activities * Assist with the management of contracted maintenance expense budgets * Working knowledge of Maintenance CC/GL accounts and classifications * Knowledge of HACCP/GMP/FDA/MIOSHA safety standards Desired Skills: * Experience leading the scheduling and maintenance for utilities and equipment such as Refrigeration, Compressed Air, Steam Generation, Process Water, and Electrical distribution. * Experience leading the scheduling and maintenance for utilities such as WFI, electrical systems and compressed air. * Experience working with Computerized Maintenance Management Systems such as SAP CMMS. * Experience leading manufacturing site Operational Excellence and Lean Manufacturing programs. * Food & Beverage, Dairy Foods, Dairy Spray Dry or Nutritional Foods manufacturing expertise working within cGMP, FDA, HACCP & OSHA compliance. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Grand Rapids, MI
Maintenance Supervisor This is a stellar opportunity within an established, thriving, and growing Midwest based complex nutritional foods market leader. You will be responsible for managing the maintenance of all equipment and machines for the manufacturing of all products in the plant. Your responsibilities will also include: * Developing best in class maintenance systems to assure a high level of support for the facility. * Identifying and integrating best practices such as Continuous Improvement, Predictive and Autonomous Maintenance. * Prioritizing activities, coordinating and scheduling maintenances, and providing leadership and direction to support manufacturing operations. * Providing support for maintaining accurate and current fixed asset inventory listing for the equipment while ensuring complete and accurate information is entered into the CMMS system. * Building technical competencies within the maintenance team. Identifying and selecting new maintenance team members that support developing technological needs. * Leads the maintenance team by providing a clear vision, defining specific and timely objectives, and using metric reporting to monitor team activities. * Managing the development and administration of operating expense and capital spending budgets for the maintenance department. * Driving a data driven Asset Health program to reduce downtime. * Conducting bench marking studies to determine best practices for the maintenance department. * Responsible for running the work schedule and payroll. Desired Skills: * Technical degree in electronics or engineering; 2-year degree acceptable, 4-year degree preferred. * 10+ years of maintenance experience and 3 years of maintenance supervisory experience with degree; 5+ years of maintenance supervisory experience without degree. * Demonstrates strong project management skills. * Strong knowledge in packaging. Knowledge of lyophilization procedures a plus. * Understanding of maintenance best practices, safety, quality, cost, HACCP, GMP, and FDA regulatory compliance. * Proven decision-making skills, strong troubleshooting, planning, prioritization, multi-tasking, and delegation skills. * Ability to communicate issues, goals, and objectives to facilitate an effective team-oriented environment. * Demonstrated ability to work with a range of technically and culturally diverse people, delivering value added business results that meet high quality * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.	Zeeland, MI
Lead Scientist, Downstream Purification Process Development This is a stellar opportunity responsible for leading downstream purification process development and tech transfer activities including Antibody Drug Conjugates. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and C&GT manufacturing capabilities. You will be charged with overseeing the following activities: * Providing Scientific leadership and project management for multiple protein purification process development, scale-up, and technology transfer processes for early stage, pilot scale, and clinical manufacturing of monoclonal antibody & recombinant protein therapeutic products and ADCs. * Developing, implementing, characterizing, and validating monoclonal antibody and recombinant protein purification processes from laboratory, pilot scale, to clinical manufacturing. * Directing activities from leading harvest, filtration, chromatography, viral clearance and recovery operations. * Leading technology transfer processes from incoming client companies. * Running downstream purification studies, process validation activities, and process characterization of recombinant protein products. * Supporting downstream processes for laboratory, early stage, and phase II clinical trial materials. * Contributing to CMC sections of NDA & BLA filings and participating in FDA audits. Desired Skills: * Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field. * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience managing downstream purification technology transfer activities with Contract Manufacturers (CMOs) or from within a CMO. * Strong Scientific, Engineering, and Manufacturing troubleshooting expertise involving downstream protein purification processes for the generation of monoclonal antibodies, recombinant protein therapeutic products or Antibody Drug Conjugates. * Experience contributing to CMC sections of BLA and NDA filings. * Expertise leading scale-up, technology transfer and process validation (PQ) activities. * Expertise working within cGMP compliance and providing GMP documentation. * Publishing scientific papers in peer-reviewed journals. * Analyzing experimental results and making recommendations for future process development. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	Los Angeles, CA
Sr. Manager, Process Engineering, BioPharma Manufacturing This is an exciting new Global Expat leadership position responsible for leading Greenfield Process Engineering operations within the World's Largest biologics CMO. It's also a once-in-a-lifetime opportunity to be part of major site and facility expansions to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and C> manufacturing capabilities. You will be charged with overseeing the following activities: * Leading and managing Process Engineering including new plant process design and utilities design for 2 new Greenfield BioPharmaceutical manufacturing facilities. * Preparing and reviewing P&ID and data sheets. * Managing POs and receipts for production equipment. * Supporting lifecycle of change and configuration for equipment and processes. * Preparing and executing validation documents (e.g., FAT, SAT). * Identifying improvement points to existing plants and CAPAs. * Executing POs and managing schedules. * Establish and maintain relationships with customers and within the organization. * Performing risk assessments in processing steps and related to equipment. * Coordinating multiple projects, documenting activities, and creating summary report templates. * Using critical thinking and judgement to diagnose problems and identify improvement opportunities. * Mentoring and training employees in duties and skills of this role as necessary. Desired Skills: * 15+ years of BioPharma industry experience in facilities Process Engineering and new plant process design. * BS or MS in Chemical Engineering, Mechanical Engineering, or related Engineering degree. * Experience leading Process Engineering for new Greenfield or Brownfield facility designs and new construction preferred. * Thorough working knowledge of GMP compliance, FDA regulations and Biopharmaceutical industry standards. * Ability to troubleshoot technical issues and design complex scientific experiments quickly and effectively. * Capability to organize, structure, and staff in a changing environment. * Excellent interpersonal skills and ability to work effectively with staff at all levels of the organization. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	Los Angeles, CA
Sr. Manager, Facilities Maintenance & Scheduling, Biopharma Manufacturing This is an exciting new Global Expat leadership position responsible for leading Production Facility Maintenance & Scheduling operations within the World?s Largest biologics CMO. It?s also a once-in-a-lifetime opportunity to be part of major site and facility expansions to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and C&GT manufacturing capabilities. You will be charged with overseeing the following activities: * Leading Maintenance operations across multiple production facilities. * Driving the commissioning and startup of new plant production facilities. * Leading GMP validation and commissioning for all production equipment. * Establishing and executing maintenance schedules including PM/CM/PCO, Construction Planning and Proposed Change Orders. * Inspecting and troubleshooting production facility overhauls. * Establishing and maintaining relationships with customers and within the organization. * Creating capital spending strategies to effectively identify and invest in company assets and needs. * Driving continuous improvement and developing strategies to push leading edge technology and innovation. * Working cross-functionally to ensure compliance with internal policies and procedures. * Leading projects and teams supporting large scale company initiatives. * Developing staff and building a high-performance team by setting expectations, ensuring ongoing coaching/mentoring, and assessing employee performance. Desired Skills: * 15+ years of BioPharma industry experience in facilities management and maintenance. * BS or MS in Chemical Engineering, Mechanical Engineering, or related Engineering degree. * Experience working with cross-functional, multi-national teams and capability to build an environment with productive collaboration. * Experience commissioning Greenfield or Brownfield facility designs and new construction preferred. * Knowledge of and ability to maintain adherence to safety regulations. * Thorough working knowledge of GMP compliance, FDA regulations and Biopharmaceutical industry standards. * Ability to troubleshoot technical issues and design complex scientific experiments quickly and effectively. * Capability to organize, structure, and staff in a changing environment. * Excellent interpersonal skills and ability to work effectively with staff at all levels of the organization. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	Los Angeles, CA
Vice President, CDO Technical Development null About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	Los Angeles, CA
Vice President, Quality, Biologics Manufacturing This is an exciting US expatriate executive leadership position responsible for overseeing strategic Quality operations within a best-in-class Asia based Global Contract Manufacturing Organization (CMO). This position is responsible for overseeing Quality Center operations within the World?s Largest biologics CMO with commercial mammalian cell culture Drug Substance manufacturing capacity, mRNA vaccine manufacturing as well as major Drug Product manufacturing operations. Your roles and responsibility will include: * Defining, developing and overseeing company Quality functions and roadmaps including Quality Strategy & Implementation, Compliance and Risk Management Strategy, Client & Regulatory Agencies Relationships Management, and Resources & Quality Innovation Management. * Overseeing Quality Strategy & Implementation within a multi-plant large scale mammalian cell culture manufacturing environment across multiple commercial biologics manufacturing with commercial drug substance and drug product manufacturing capacity. * Overseeing and managing the Quality organization?s budget, ensuring all budgets meet company targets. * Communicating, deploying and executing the company?s Quality roadmap across the organization. * Ensuring the adherence to the company Compliance Risk Management program which manages risks associated with deviations from regulatory requirements. * Providing input on issues, opportunities, risks, and risk management to clients. * Supporting Regulatory submissions and inspections across sites, advising on best regulatory path to accelerate approval. * Leading, developing, and executing quality and regulatory initiatives in compliance with company procedures and ethics. * Supporting Innovation strategies in line with quality processes, including reporting of Performance of a Lean culture. * Ensuring necessary resources are available to support the execution of quality, regulatory, and compliance objectives. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field. * 20+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large scale or commercial biologics manufacturing environment. * Exceptional strategic team leadership and functional Quality organizational leadership experience. * Strong Scientific and Engineering expertise leading Quality Operations for the generation of monoclonal antibodies, recombinant protein therapeutic products or commercial mRNA vaccines. * Experience leading multiple Quality operations, organizational strategies, roadmaps and functions for large scale organizations. * Expertise leading Compliance initiatives within a large scale organization. * In depth understanding of life science operations and business practices, throughout product life cycles, for the development of drugs and medical devices. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	San Francisco, CA
Sr./Principal Scientist, ADC Conjugation & Manufacturing This is a stellar opportunity responsible for leading ADC conjugation processes, tech transfer and manufacturing operations. This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and Cell Therapy manufacturing capabilities. You will be charged with overseeing the following activities: * Leading the optimization of processes for low-yield, highly sensitive ADC conjugation processes. * Incorporating various generations of external site-specific conjugation platform technologies. * Running processes beyond large scale and small scale with consideration of scalability (i.e., commercial and clinical scale). * Providing input on payload handling procedure set up and for facility design from a human safety perspective. * Supporting the standardization of processes and communications to build efficiency within cross-functional teams. * Assisting and providing input for facility process design, equipment validation and equipment selection. * Providing support for document generation (SOPs, batch records, etc.). * Leading and supporting the technical process clarification with clients. * Providing input and supporting facility design processes. * Supporting quality audits and global regulatory inspections. Desired Skills: * 10-15+ years working experience with ADC biopharmaceuticals, including manufacturing process development. * BS, MS or Ph.D. in Biochemistry, Biology, Organic Chemistry, Chemistry, or related Biological Sciences degree. * Experience working with cross-functional, multi-national teams and capability to build an environment with productive collaboration. * Proven experience with ADC conjugation processes, tech transfer and manufacturing operations for commercial ADCs and monoclonal antibody therapeutics. * Significant knowledge of DAR (Drug-Antibody Ratio) and identification of binding sites (Cysteine, lysine, etc.). * Experience leading and managing the ADC conjugation manufacturing set up (including ADC DP) and operations. * Familiarity with FDA guidance on analytical method development for ADCs and monoclonal antibody therapeutics. * Experience contributing to CMC, IND and BLA regulatory filings and submissions. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	Los Angeles, CA
2022 -Business Trip - Center Leader / CMO Leader null About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	San Francisco, CA
Vice President, Quality Control, BioPharma Manufacturing This is an exciting US expatriate executive leadership position responsible for overseeing all Quality Control operations within a best in class Global Contract Manufacturing Organization (CMO). This position is responsible for overseeing all Quality Control operations within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture Drug Substance manufacturing capacity, mRNA vaccine manufacturing as well as major Drug Product manufacturing operations. Your roles and responsibility will include: * Overseeing Quality Control Operations within a multi-plant large scale mammalian cell culture manufacturing environment across 4 Manufacturing Plants with 362,000L to 620,000L commercial drug substance manufacturing capacity. * Overseeing and functional QC leadership teams and 500 person staff responsible for QC Microbiology, Environmental Monitoring, Raw Material Testing, in-process, lot release, stability and microbiology testing of therapeutic bulk drug substance and final drug products. * Leading teams responsible for QC Stability and Reference Standards Management activities. * Driving the strategic direction and QC Department roadmap and strategies in support of the company?s Quality vision. * Leading Quality Control Audits and Inspection Management capabilities including Client audit and inspections. * Driving QC Innovation Management to ensure resources are at all-time availability to support QC processes. * Leading projects for setting up new QC laboratories including new equipment qualification and validation. * Leading analytical methods qualification, methods validation activities and incoming tech transfer activities from external clients. * Leading QC related technical troubleshooting including deviation handling and investigations. * Supporting Business Development efforts for attracting new clients and projects. * Ensuring Lab Safety, Pre-Approval Inspection/PAI readiness and hosting FDA & EMEA audits & inspections. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field. * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large scale or commercial biologics manufacturing environment. * Exceptional strategic team and functional QC organizational leadership * Strong Scientific and Engineering expertise leading Quality Control laboratories for the generation of monoclonal antibody and recombinant protein therapeutic products. * Experience leading QC Stability, Reference Standards Management, and QC Stability testing and QC Stability studies. * Expertise leading QC methods development, methods qualification, and methods validation activities. * Experience overseeing QC Audits, QC Inspections, ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	New York, NY
Director of Project Management, BioPharma CMO This is an exciting US expatriate project leadership position responsible for overseeing all drug substance development from upstream mammalian cell culture development, downstream purification development, manufacturing activities and quality systems management. This is a unique opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities: * Serving as the liaison between Clients to manage new orders and production campaigns * Plan, execute, and finalize projects according to strict deadlines, milestones and within budget. * Providing team leadership on projects of all mammalian cell culture process development, downstream purification development, and analytical methods development/characterization for the generation and manufacturing of monoclonal antibody and recombinant protein therapeutic products. * Scheduling projects with QA and QC, to ensure that all processes and productions comply with regulatory guidelines as well as ensuring controlled environments are maintained for the manufacture of high-quality products. * Leading project management of complex tech transfers between client sites and manufacturing facilities. Desired Skills: BS, or MS in Chemistry, Biochemistry, Biology, Chemical Engineering or related Life Sciences field. 15+ years of Project Management experience as it relates to BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong background leading and managing projects for large CMOs * Expertise leading projects on upstream mammalian cell based cGMP biologics manufacturing, downstream purification, analytical methods technology transfer, and process validation activities. * Experience ensuring quality assurance, quality control and experience working within cGMP compliance and providing GMP documentation. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/	San Francisco, CA
Senior Manager Human Factor Engineering BPG Innovation Team null About the Company: This is an exciting opportunity with a leading company offering full mammalian cell process development and the ideal candidate will responsible for driving implementation of Upstream based collaboration projects as a member of the Bioprocessing Collaboration Team.	Saint Louis, MO