Company Job Listings

Job Title	Location
Director, Upstream Manufacturing Science and Technology, Biologics Manufacturing This is an exciting leadership opportunity responsible for overseeing Upstream Manufacturing Sciences & Technology (MSAT) operations for large scale clinical and commercial manufacturing of recombinant protein products including monoclonal antibodies, fusion proteins, bispecifics and ADC?s. It's also an exciting opportunity to lead major growth efforts due to new pipeline advancements and facility expansion projects. Your roles and responsibility will include: * Leading an Upstream MSAT team members and projects for the manufacturing of mAbs, fusion proteins, bispecifics and ADC?s. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing technical leadership and subject matter expertise relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead upstream related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert for fed-batch upstream cell culture activities ranging from vial thaw, inoculum, media optimization, cell line development, and stainless steel bioreactor operations. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Training upstream staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and CMC sections of regulatory filings. * Author, review and approve CMC documentation for health authority responses and regulatory filings. * Contribute in the evaluation and implementation advanced technologies and capabilities including Process Automation Systems, Continuous Manufacturing, Process Intelligence, and Process Monitoring systems. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry or related Life Sciences/Engineering field. * 10+ years of BioPharma, Biopharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong Scientific and Engineering experience leading upstream cell culture manufacturing activities involving vial thaw, inoculum, media optimization, cell line development, and stainless steel bioreactor operations. * Expertise leading fed-batch mammalian cell culture operations. Expertise in perfusion processes a plus. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, multivariate statistical analysis, JMP, OSI/PI data historian software, process robustness studies, and Six Sigma Lean Manufacturing. * 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.	Boyds, MD
Manager Automation Systems Network Infrastructure, Biologics Manufacturing his is an exciting position responsible for leading a team managing a 5 person team supporting key IT Operations and Network infrastructure projects for the execution of BioPharmaceutical PLC and DCS control systems such as Emerson DeltaV, Allen Bradley, Rockwell Automation, PAS/X MES Systems, as well as Building Management Systems. This is a high priority leadership position within a state-of-the-art large scale commercial mammalian cell culture biologics manufacturing plant. You will also be responsible for the following activities. - Oversee and support key IT operations and process control network infrastructure for DeltaV and Rockwell Automation Systems including operating systems, network security tools, application servers and data storage systems. - Support the IT Infrastructure for Emerson DeltaV and Rockwell automation and controls systems projects within a large scale commercial mammalian cell culture biologics manufacturing plant. - Oversee and determine timeframes for major automation digital system projects including system updates, upgrades, migrations and outages. - Develop and implement digital systems policies and best practices for the Digital Systems group including creating, maintaining, and approving SOPs and PCN system lifecycle documents. - Maintain, configure, and ensure reliable operation of Process Control Systems networks, virtual environment, and integration with automated control systems. - Collaborate with site Automation, Business Systems, and IT teams to proactively recommend digital system solutions for key automation and Business System projects. - Maintain PCN system security and access control procedures to prohibit unauthorized access to settings and networks. - Support regulatory efforts through audit participation and quality systems serving a as a Subject Matter Expert during regulatory inspections and internal investigations. - Manage the performance, training, workflow and development of the Automation Systems team of engineers and support staff including planning, scheduling, work metrics, design, and execution of technical projects. - Manage CAPEX and OPEX costs within the department. Desired Skills: - BS Degree in Computer Science, Computer Engineering, Information Technology, Biochemistry, Chemical Engineering or related Engineering or Life Sciences field. - 5+ years of IT industry experience required. - 3+ years of BioPharma or Pharmaceutical industry experience required. Preferably in an Automation Engineering or Automation Systems position. - Familiarity with industrial PLC and DCS control systems such as Emerson DeltaV, Allen Bradley or Rockwell Automation, MES Systems such as PAS/X, as well as building management systems (BMS/EMS). - Managerial experience overseeing a team of technical or Engineering professionals. - Experience developing Computerized System lifecycle documentation, design documents, technical evaluations, and test plans within cGMP and GAMP compliance. - Knowledge of Networking and IT infrastructure including TCP/IP network, VLAN and basic principles of switches and router configuration and industrial communication protocol such as OPC and DeviceNET. - Expertise in IT governance, including support & system management, business continuity and forecasting. - Biopharmaceutical industry experience working within cGMP or GAMP industry standards and practices as well as CSV and Quality principals relating to the validation of computerized systems and electronic data. 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.	Frederick, MD
Director, Natural Beverage Brand Development This is an exciting marketing leadership opportunity within an ultra-innovative category defining all-natural food and beverage products spin-off company. You will be charged with overseeing and growing product sales, digital marketing, product development and branding activities. Your overall roles and responsibilities will include: - Serving as a key Brand Builder and Brand Strategist for launching innovative all-natural food and beverage product brands by developing strategic marketing and branding initiatives. - Developing and driving marketing goals, product branding, promotions and merchandising strategies. - Driving brand positioning and activation, segmentation analysis, new product development, commercialization, strategic planning, budgeting, forecasting, P&L responsibilities and, market data analysis. - Partnering alongside an aggressive direct-to-consumer e-commerce initiative and supporting ongoing web presence strategies, SEO, websites, landing pages and content marketing. - Working directly with external third-party PR and Creative Marketing Agency partners to provide essential marketing and creative services. - Partnering with Social Media teams to further develop brand awareness and sales conversions. - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and sales analytics. - Serving as key driver of the company's leadership team. Desired Skills: - 5-10+ years of successful food product marketing experience driving sales of natural foods, beverage, dairy, nutritional products or related CPG products. - BS in Marketing, Business, Operations Management or related field. MBA, MS or Ph.D. in Food Science a plus. - Successful experience building early stage natural foods or nutritional products and brands into category and market leaders. - Marketing experience launching, promoting and developing innovative beverage categories including sparkling drinks, energy drinks, cold pressed juices, infused drinks, cold brew coffee, probiotics, almond milk, dairy alternatives, sports nutritional beverages, craft beer, Kombucha or low-acid aseptic beverages. - Knowledge and experience overseeing digital marketing strategies, online content, website strategies and e-commerce technologies. - Entrepreneurial and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. - Exceptional Business Operations and Financial Management experience overseeing forecasting, budgeting and accounting activities. - Exceptional leadership, vision, entrepreneurial spirit and drive for success. - thirty * 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
Master Brewer / Cicerone Seeking an experienced and knowledgeable Brewing Consultant/Beer Quality Analyst to help produce high-quality beer that appeals to consumers. The ideal candidate will have expertise in analyzing beer quality and experience in brewing, including knowledge of brewing techniques and processes that produce exceptional beer. Responsibilities: Analyze beer quality, including taste, color, foam, and body. Advise on and oversee the technical aspects of the brewing process to ensure the production of high-quality beer. Troubleshoot any issues that arise during the brewing process. Recommend changes to the brewing process to improve the quality of the beer. Work collaboratively with the brewing team to develop new beer recipes and ensure consistent quality. Desired Skills: Desired Skills and Experiences: Master brewer and/or Cicerone certification, preferably with a scientific background, such as in chemistry. Completion of the Beer Judge Certification Program (BJCP), Cicerone Certification Program, or other certification programs in beer quality analysis. In-depth knowledge of protein chemistry and carbohydrate chemistry, with experience in brewing adjuncts such as wheat, sorghum, and millet. Experience brewing a wide range of beer styles, including ales, lagers, stouts, and uncommon beer styles, with a high adjunct concentration. Ability to troubleshoot problems in the brewing process and make recommendations to improve beer quality. Strong communication and collaboration skills, with the ability to work effectively with the brewing team and other departments. Willingness to work part-time as a consultant. Start-up brewery experience preferred. The successful candidate will be compensated based on their experience and qualifications. If you have a passion for brewing and a drive to produce exceptional beer, we encourage you to apply for this exciting opportunity 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, Food Sciences and Low-Acid 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 Manufacturing, Marketing and Product Branding Operations. 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. Developing the site operational effectiveness and vision and direction of the low acid aseptic beverage manufacturing and operational strategy in conjunction with the company?s long-term vision. Leading Marketing and Brand Building strategies to ensure the commercialization and continued growth of innovative branded products. Overseeing the management of all areas of business operations including Manufacturing, Supply Chain, Quality, Engineering, Marketing, Business Development 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. Directing the scheduling of manufacturing operations and key manufacturing personnel while working within cGMP, HACCP and ISO compliance and meeting quality standards. Driving the reduction of Cost of Goods through budgetary, financial and logistical management while ensuring the highest level of Quality and Regulatory Compliance. Desired Skills: BS, or MS in Food Science, Biology, Chemistry, Microbiology, Chemical Engineering or related Scientific/Engineering field. MBA a plus. 10+ 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. Strong Marketing, Sales or Brand Building expertise with past experiences leading product launches, commercialization and growth of innovative food and beverage products. 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. 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
Sr Scientist/Project Leader/Director, Plant-Based Functional Foods This is an exciting entrepreneurial leadership opportunity within an ultra-innovative category defining plant-based food & beverage, functional foods and nutritional products company with new research labs and expansive growth plans. You will be charged with overseeing new product development & innovation for a new line of vegan plant-based dairy alternatives and functional foods from product launch through to commercialization. Your overall roles and responsibilities will include: - Overseeing Product Development and Innovation to introduce and grow non-dairy food & beverage products including sour cream, cream cheese and yogurt products and category defining all natural plant-based dairy food alternatives. - Innovating and developing new plant-based functional food and beverage products seeking inspiration from successful International brands within the Japanese, Korean or Asian markets such as smoothies, drinkable ice cream, lactic pouch drinks, pouch jelly drinks and functional sports beverages. - Partnering with marketing, scientific and technical core team members to define project scope, success criteria, and critical paths while maintaining Stage Gate methodologies from innovation, R&D, process scale up, sensory testing, product launch through to successful completion of post-launch reviews. - Understanding and leveraging the nutritional impact value of functional food products, interpreting results and working with Marketing to further product development efforts. - Driving Scientific Marketing campaigns through content creation, PR campaigns and writing for scientific whitepapers and informational documents. - Driving the success of Business Operations through forecasting, budgeting, P&L accountability, development of KPIs and e-commerce analytics. - Serving as member of the company?s leadership team overseeing and developing the emerging Health and Nutrition Science Division. Desired Skills: - 3+ years of successful product development and marketing experience from within plant-based foods, functional foods, dairy alternative, meatless foods, nutritional products, nutraceutical, infant formula, toddler products and or food-pharma related industries. - MS or Ph.D. in Food Science, Nutritional Science, Nutrition or related scientific field. MD or MBA a plus. - Experience developing or commercializing food and beverage brands in Asia including Japan or South Korea markets such as smoothies, drinkable ice cream, lactic pouch drinks, pouch jelly drinks and functional sports beverages. - Scientific expertise developing and commercializing non-dairy sour cream, cream cheese and yogurt products. - Successful experience building early stage natural foods, functional foods, organic foods, plant-based foods, nutraceutical, nutritional products and non-dairy alternative brands into category market leaders. - Project Management experience developing nutritional food products from discovery, R&D, development, product launch through to commercialization phases. - Process Innovation expertise working with aggressive Stage-Gate methodologies. - Scientific lab expertise working with functional foods, plant-based foods, nutritional ingredients, flavor chemistry, nutritional food components, emulsions or sensory science a plus. - Strong publication, presentation and patent record. - Experience working within FDA, GMP, HACCP and FOSHU (Food for Specified Health Uses) regulations. - Entrepreneurial, visionary and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. - 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
Sr Director/VP, Business Development and Ingredient Sales, Plant Based Foods This is a unique sales leadership opportunity within the East Coast?s largest low-acid aseptic beverage manufacturing operation with industry leading plant-based beverage R&D and manufacturing technologies. You will be charged with leading Business Development for a combination of low-acid aseptic contract manufacturing and co-packing capabilities alongside innovative plant-based ingredients and ingredient bases. This is a key growth position serving on the site leadership team within a 500+ person company experiencing rapid client growth, manufacturing expansion and increased production capabilities. It?s also an exciting opportunity to contribute to the rapid manufacturing of low acid aseptic products including Almond & Plant Based Milks, Coffee Creamers, Protein Shakes, RTD Coffees, Smoothies and Energy Drinks. You will be also be charged with overseeing the following activities. * Driving sales by calling on major food, nutritional foods, large beverage and emerging beverage client companies seeking low-acid aseptic Contract manufacturing and co-packing capabilities. * Working alongside Business Development, Sales and Marketing teams to ensure continuation and growth of revenue generation through the selling Contract manufacturing and co-packing capabilities for manufacturing and packaging operations. * Driving the sales of unique and innovative plant-based ingredients and ingredient bases derived from grains, nuts and seeds. * Driving the combination of sales of plant-based ingredients with low-acid aseptic contract manufacturing and co-packing capabilities. * Serving as a member of the site leadership to ensure the attainment of revenue and profit goals with responsibility for profit/loss and the achievement of current and long-range objectives. * Developing the vision and direction of the low acid aseptic beverage manufacturing and operational strategy in conjunction with the company?s long-term vision. * Working collaboratively with R&D, Supply Chain and Manufacturing teams to ensure smooth manufacturing processes supporting clients low acid aseptic manufacturing operations. * Effectively opening and closing sales cycles through qualifying, presenting, proposing, closing and managing key accounts. Desired Skills: * BS, MS or MBA in Business, Nutrition, Food Science, Biology, Chemistry, Microbiology, Engineering or related Scientific/Engineering. * 10+ years of successful Sales/Business Development experience selling low-acid aseptic foods manufacturing Contract manufacturing and co-packing capabilities. * Experience selling key food or beverage ingredients such as grains, nuts, seeds, coffee or dairy products. * Experience selling to clients and customers manufacturing low acid aseptic products including Almond & Plant Based Milks, Coffee Creamers, Protein Shakes, RTD Coffees, Smoothies and Energy Drinks. * Entrepreneurial, visionary and strategic leadership experience with the ability to work within a dynamic fast paced ultra innovative environment. * Exceptional Business Operations and Financial Management expertise with demonstrated P&L oversight, forecasting, budgeting and accounting experiences. * Exceptional phone, electronic, and in-person Sales expertise with the ability to develop targeted prospect lists, sales contacts and manage sales efforts within a CRM system. * Ability to travel extensively nationwide. Close proximity to a major airport preferred. 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
Senior Manager, Supply Chain Planning, Cell & Gene Therapies This is an exciting opportunity charged with overseeing and managing the logistical operations associated with autologous cell therapies from managing the flow of materials from cell collection through manufacturing and distribution. This is a critical position charged with ensuring the success of clinical supply materials and the long-term efficacy of life-saving cancer cell therapies. Your overall responsibilities will include: * Serve as the key Logistics and Supply Chain expert supporting the time critical and temperature sensitive patient sample journey from Hospitals/Intake Centers, including scheduling Cryopreservation and Manufacturing, logistics, material movement, and collaboration with transportation providers. * Support Cell Therapy Clinical Operations, including new site onboarding, management, forecasting, and distribution of cell therapy therapeutics in the US and EU. * Manage the End-to-End logistics processes, from patient intake to final patient shipping. * Support Order Management processes, including order generation, changes, shipment, and delivery scheduling. * Collaborate with Manufacturing, Quality teams, and CMO partners to execute production plans and patient schedules. * Implement key performance measures to improve product transport and cost-effective on-time delivery. * Manage logistics couriers, external warehouses, and supplier relationships. * Manage standardized processes, shipping qualification, equipment validation, process evaluation, and documentation for autologous cell therapy supply chain processes. Desired Skills: * BS degree in Business, Supply Chain Management, Microbiology, Biology, Chemistry or related field. * 8+ years of BioPharma, Biopharmaceutical, Pharmaceutical or Biotechnology industry experience working within a GMP environment. * Prior Logistics or Supply Chain Management experience working with time critical and temperature sensitive patient samples, cell therapies, gene therapies or related biologic materials. * Expertise working with SCM or ERP systems such as SAP or Oracle. * Experience managing relationships with TPL, Shipping and Logistics partners. * Ability to work within a fast-paced environment while ensuring the highest level of Quality and GMP compliance. * thirty 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. MSAT Specialist, Cell Therapies Manufacturing This is an exciting new opportunity responsible for leading Manufacturing Sciences & Technology (MS&T) related activities for novel cell therapy manufacturing and process development advancements. Your roles and responsibility will include: * Leading MSAT projects related to cell therapy manufacturing process improvements and deviation resolutions. * Developing and implementing manufacturing strategies for resolving complex issues and deviation resolutions for manufacturing investigations and process improvements. * Developing and executing investigation plans, protocols and reports for root cause analysis. * Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments. * Providing subject matter expertise relating to upstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to upstream cell culture related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert for aseptic manufacturing and cell culture activities ranging from production in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Training downstream staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings. Desired Skills: * BS or MS in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, aseptic manufacturing and cell culture activities in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma. * thirty 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
Manager, Quality Control, Microbiology, Cell Therapies This is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for ensuring the highest standards of Quality Control Microbiology for life-saving therapies. Lead a cutting-edge team, oversee operations with focus on environmental monitoring and microbial testing techniques (bioburden, endotoxin, gram stain, sterility). Drive GMP-regulated QC microbiology tests, ensure compliance throughout product development life cycle, including lot release, stability testing, method qualification, and validation. Key Responsibilities: * Lead and manage a QC Microbiology team including a Supervisor and talented analysts overseeing cGMP QC testing for lot release and stability of for life-saving drug products. * Drive the technical transfer, qualification, and validation of microbiology test methods for in-process materials, lot release, and stability as needed. * Spearhead the environmental monitoring program for a state-of-the-art facility, ensuring the highest standards of cleanliness and safety. * Author, review, and approve SOPs, protocols, reports, specifications, and GMP related QC documents. * Conduct timely trend analysis and generate comprehensive reports for environmental monitoring data. * Take the lead in investigations for out-of-specification test results and implementing corrective actions. * Provide vital support to product stability programs, including protocol generation, execution of stability testing, data analysis, and reporting. * Play a key role in site contamination control programs, ensuring a safe and sterile environment for our groundbreaking therapies. * Oversee the maintenance and development of a comprehensive microbial identification database, covering all in-house isolates from various monitoring programs. * Collaborate on site qualification, validation, and commissioning activities as required. * Serve as a qualified trainer to support the development of the microbiology team members. * Foster positive relationships with internal and external partners and technical subject matter experts implementing performance management processes, routine meetings, onsite visits, and issue notification. * Thrive in a fast-paced environment, consistently delivering high-quality and accurate results with minimal supervision. Desired Skills: * BS or MS in Microbiology, Biology, Chemistry, Biochemistry or related Life Sciences field. * 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Hands-on expertise leading QC microbiology testing and assays including sterility testing, bioburden testing, environmental monitoring, microbial identification and site contamination control testing. * Experience leading Microbiology Supervisors and staff. * Expertise leading microbiology related investigations with successful experience resolving related deviations. * Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness. * Expertise leading microbiology related methods development, methods qualification, and methods validation activities. * thirty 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
Sales Manager null About the Company: We have been an industry leader for over 60 years in the industrial equipment sector. As a Manufacturer of our own brands as well as holder exclusive North American rights to international branded products, we are uniquely positioned to benefit from our stability while deploying cutting-edge productivity improvements.	Dallas, TX
Senior Director, Direct Sales Exciting Job Opportunity: Director of Revenue Generation and Sales Growth! Position Objective: Are you a dynamic and results-driven leader with a passion for driving revenue and growth? We have an exhilarating opportunity for a Director of Revenue Generation and Sales Growth! As the Sr. Director, you will be the driving force behind our company's sales success, crafting innovative strategies to achieve outstanding results. Organization: You'll be an integral part of our executive team, reporting directly to the Chief Sales Officer. Responsibilities: Charting the Path to Success: Develop and execute groundbreaking sales strategies that push boundaries and elevate our brand to new heights. Expanding Horizons: Cultivate new and existing customer relationships, exploring diverse markets beyond our traditional territories. Empowering Success: Foster a culture of achievement and excellence, inspiring our sales team to surpass their goals and unlock their true potential. Harnessing Cutting-Edge Tools: Utilize the latest CRM software to streamline sales processes, boosting efficiency and skyrocketing win rates. Pioneering Growth: Collaborate with our talented team to create a visionary 3-year sales development plan, and lead the charge in recruiting exceptional sales professionals. Mastering the Art of Solutions: Become a sales expert, supporting our team in navigating financing approvals, negotiating leases, and managing logistics. Data-Driven Decision Making: Leverage our ERP and advanced sales reporting systems to make strategic choices, optimizing the use of company resources. Elevating Customer Experience: Promote a customer-centric approach, ensuring that our clients' expectations are exceeded at every turn. Desired Skills: About the Company: We have been an industry leader for over 60 years in the industrial equipment sector. As a Manufacturer of our own brands as well as holder exclusive North American rights to international branded products, we are uniquely positioned to benefit from our stability while deploying cutting-edge productivity improvements.	Inwood, NY
Sr Specialist, Downstream MSAT, Biologics Manufacturing This is an exciting opportunity responsible for leading downstream MSAT operations for large scale and commercial manufacturing of recombinant protein and monoclonal antibody therapeutics. It?s also a fantastic opportunity to grow your career within Maryland?s top manufacturing center with a focus on manufacturing treatments for cancer and autoimmune diseases. Your responsibilities will include: * Leading technical support and investigations for downstream purification processes and unit operations for recombinant protein and monoclonal antibody therapeutics. * Supporting commercial production and tech transfer of manufacturing processes. * Conducting process performance monitoring, conceptualizing and implementing process improvement strategies, and developing process models. * Conducting and/or participating in multiple projects that range in complexity and technical demand within a specific area/field. * Initiating, implementing, planning, directing, and executing investigations to resolve deviations, understanding process trends, and/or improving process models. * Balancing day-to-day technical support for manufacturing operations, long-term projects, and investigations. * Maintaining technical expertise on several process unit operations. * Serving as mentor and role model to other associates or lab personnel, with occasional supervision of lower-level scientists or associates. * Writing sections of regulatory documents and representing operations during regulatory inspections. Desired Skills: * BS or MS degree in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry, or related Life Sciences/Engineering field. * 3+ years of Biopharmaceutical, Pharmaceutical, or Biotechnology industry experience. * Downstream purification and process development expertise in column chromatography, filtration, TFF, and UF/DF unit operations. * Knowledge of GMP manufacturing principles and documentation. * Working knowledge of Biologics and/or relevant work experience in purification of large molecules in therapeutic antibodies, vaccines, or injectables. * Strong Scientific and Engineering knowledge and ability to perform downstream purification techniques. * Previous experience with statistical analysis and/or modeling (i.e., JMP, Minitab, SIMCA, and/or Discoverant a plus). * Knowledge of QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma manufacturing. * thirty About the Company: This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics.	Portsmouth, NH
DeltaV Automation Engineer, BioPharma Manufacturing This is an exciting opportunity responsible for performing a broad set of automation & controls systems engineering activities within a major NY based state-of-the-art large scale commercial biologics manufacturing facility. It?s a unique opportunity to join an expanding Biologics Contract Development and Manufacturing Organization with major growth efforts due to new client acquisitions and ADC facility expansion projects. Additional responsibilities of this role will include: * Design and implement engineering solutions for process equipment controls, S88 batch controls, hardware, device integration, and server support. * Collaborate with process experts to determine automation requirements and develop specifications. * Test designs, provide 24/7 support for manufacturing systems, and work in a high compliance environment. * Manage automation projects from start to finish, ensuring processes meet user requirements. * Influence vendor roadmaps to align with company strategies. * Support the operation of manufacturing systems in Syracuse, NY. * Investigate and address root causes of digital plant problems. * Provide automation expertise for deviation investigations and technical solutions. * Configure, test, and implement process control solutions for complex technical issues. * Document knowledge base for issue resolution and future activities. * Oversee and own automated manufacturing processes, including batch recipes and hardware components. * Lead Lean OpEx initiatives and collaborate with cross-functional teams. * Conduct job activities in compliance with cGMP and EHS requirements. * Provide training on automated solutions to operations staff and automation colleagues. Desired Skills: * BS degree in Biochemical Engineering, Chemical Engineering, Electrical Engineering, Mechanical Engineering or related Engineering field. * 3-5+ years of experience working with Emerson DeltaV automation systems within a BioPharma, Biotechnology, Pharmaceutical Manufacturing, Food & Beverage Manufacturing or related regulated industry. * Expertise with process control and automation systems including the Emerson DeltaV automation systems. * Expertise creating S88 batch recipes and S88 standards. * Experience programming DeltaV, PLC and HMI systems. * Ability to create and understand process design documents such as P&IDs, electrical schematics, and loop drawings. * 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.	East Syracuse, NY
Automation Engineer null About the Company: This is an exciting opportunity within an established global BioPharma company with a major operational and expanding manufacturing site in Central New Hampshire. It's also an opportunity to join a company with industry leading benefits, PTO days and work life balance.	Enfield, NH
Facilities Engineer, BioPharma Manufacturing This is a stellar opportunity within an established global BioPharma company with a major operational and expanding manufacturing site in Central New Hampshire. You will be responsible for implementation of manufacturing support processes, instrumentation and equipment for offices, laboratories, and manufacturing Facilities. Your responsibilities will also include: * Providing support to designated manufacturing operations and Facilities including GMP critical utilities, cleanrooms, HVAC, high-purity water systems, WFI, compressed air and other support utilities. * Troubleshooting equipment and systems to support deviations, corrective actions, and related manufacturing impact/quality issues. * Collaborating with quality, manufacturing sciences, and manufacturing to track and evaluate process trends or issues. * Assisting in procurement, installation, engineering start-up and validation activities related to systems and equipment. * Participating in implementation of procedural improvement changes. * Serving as the back-up point of contact for solvent, waste and emissions control, and related cost optimizations/efficiencies. * Testing equipment or troubleshooting problems by execution of engineering runs. * Supporting other activities as instructed. * Ensuring job duties and responsibilities are performed in a compliant and ethical manner, in accordance with healthcare laws, regulations, and industry codes. Desired Skills: * Bachelor's degree in engineering or related discipline. * 3+ years of working experience with pharmaceutical process or biotechnology. * Knowledge of pharmaceutical utility operations, cleanrooms, and building systems. * General knowledge of GMPs for Pharmaceutical manufacturing is preferred. * Base knowledge and understanding of Piping and Instrumentation Diagrams (P&IDs) and facility drawings desired. * Strong oral and written communication skill. * Ability to adjust quickly for changes in work priorities. * thirty About the Company: This is an exciting opportunity within an established global BioPharma company with a major operational and expanding manufacturing site in Central New Hampshire. It's also an opportunity to join a company with industry leading benefits, PTO days and work life balance.	Enfield, NH
Sr. Facilities Engineer, BioPharma Manufacturing This is a stellar opportunity within an established global healthcare company focused on driving change to defeat diabetes and other serious chronic diseases. You would be responsible for implementation of manufacturing support processes, instrumentation and equipment for offices, labs, and manufacturing. Your responsibilities will also include: * Providing support to designated manufacturing operations areas. * Troubleshooting equipment and systems to support deviations, corrective actions, and related manufacturing impact/quality issues. * Collaborating with quality, manufacturing sciences, and manufacturing to track and evaluate process trends or issues. * Assisting in procurement, installation, engineering start-up and validation activities related to systems and equipment. * Participating in implementation of procedural improvement changes. * Serving as the back-up point of contact for solvent, waste and emissions control, and related cost optimizations/efficiencies. * Testing equipment or troubleshooting problems by execution of engineering runs. * Supporting other activities as instructed. * Ensuring job duties and responsibilities are performed in a compliant and ethical manner, in accordance with healthcare laws, regulations, and industry codes. Desired Skills: * Associate?s or Bachelor?s degree in engineering or related discipline. * 1-2+ years of working experience with pharmaceutical process or biotechnology. * Ability to receive and apply instruction on routine work and new assignments. * General knowledge of GMPs is preferred. * Base knowledge and understanding of Piping and Instrumentation Diagrams (P&IDs) and facility drawings desired. * Strong oral and written communication skill. * Ability to adjust quickly for changes in work priorities. About the Company: This is an exciting opportunity within an established global BioPharma company with a major operational and expanding manufacturing site in Central New Hampshire. It's also an opportunity to join a company with industry leading benefits, PTO days and work life balance.	West Lebanon, NH
Technical Development Leadership (TD) & NY/NJ Business Trip 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/	New York, NY
Bio R&D Center / I Lab, Principal Scientist 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
Bio R&D Ab Technology, Principal Scientist 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
Sr. Manager/Director BioPharma Marketing Communications, Expat in South Korea This is a stellar opportunity responsible for developing and implementing Marketing Communications strategies within the World?s Largest Biologics Contract Manufacturing Organization with expanding commercial monoclonal antibody manufacturing capabilities. This is a once-in-a-lifetime Global Expat leadership opportunity to live and work in the Songdo, South Korea ?City of the Future?. You will be charged with overseeing the following activities: * Developing, implementing and executing marketing and promotional projects to support Executive level leadership and key business stakeholders for the advancement of Biologics CDMO/CMO businesses. * Manage a diverse set of Marketing Communications projects for B2B Healthcare marketing campaigns. * Facilitate collaboration across the company, global institutes, PR/Marketing agencies, and partners to identify communication needs, shared strategies and aligned engagement efforts. * Develop various global PR/marketing vehicles including but not limited to online/digital content, conference/event/sponsorship components, scientific papers, and client-targeted promotion materials. * Develop innovative marketing content via the creation of Online videos and video editing tools. * Managing paid online campaigns via Google, Facebook, Instagram, LinkedIn and other major online sites. * Coordinate and support English based external communications including company website, social media channels, CRM, and industry conferences. * Utilize internal feedback, marketing analytics to monitor and adjust the effectiveness of Marketing Communications strategies and tactics. Desired Skills: * 10+ years of Marketing, Marketing Communications, Public Relations or Advertising Agency experience within a large Global company environment. * BS or MS Degree in Marketing, Communications Management or MBA. * Experience working within the Biotechnology industry, Pharmaceutical Industry, Life Sciences, Healthcare or CDMO/CMO (Contract Manufacturing Organization) preferred. * Expertise in Content Creation, Video Content Production, Video Editing, Digital Marketing and Social Media Management. * Expertise generating online organic and paid media including Google ad placement, web content and white papers. * Expertise utilizing Marketing Automation or CRM software such as Salesforce Pardot for lead management and customer management. * Excellent English verbal and written communication proficiency. * Korean language proficiency required with an emphasis on English fluency & proficiency. 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
Lead Scientist, Mammalian Cell Line Development This is a stellar opportunity responsible for leading upstream mammalian cell line development activities and innovative platform development for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Serving as a technical and scientific lead for advanced stable cell line development, cell line optimization and mammalian expression technologies for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. * Leading CLD efforts including DNA cloning, vector construction and the characterization of production cell banks. * Performing clone selection, CHO cell transfection and selection processes to develop stable cell lines with high productivity. * Evaluate and introduce strategic, innovative and novel technologies to improve cell line development processes and therapeutic protein production with the consideration of IP landscape of novel technologies. * Oversee cell line development project plans, including raw materials and equipment availability in preparation of laboratory and pilot-scale runs. * Developing cell line and upstream processes from thaw, pilot scale-up, technology transfer through to clinical manufacturing. * Serving as the technical project lead for the development of robust high performing robust mammalian cell lines with emphasis on transferability to cGMP manufacturing. * Working collaboratively with upstream and downstream process development teams and analytical development teams to support drug substance development. Desired Skills: * 5+ years of Biotechnology industry experience leading mammalian cell line development processes. * MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field. * Cell line development experience for the generation of complex monoclonal antibodies including ADC?s, Bispecific Antibodies or Fusion Proteins. * Expertise utilizing of High-Throughput automated liquid handling systems such as TECAN or Hamilton STAR. * Expertise utilizing AMBR bioreactors, FACS analysis, Flow Cytometry, Octet, Guava or Cedex technologies. * Hands-on expertise in cell banking, cell thawing and cell freezing technologies. * Expertise in DNA cloning, vector construction and design, and genetic characterization of production cell banks. * Knowledge of a variety of cell lines and mammalian expression systems including CHO, HEK and NS0. * Knowledge of PAT technologies, GMP guidelines and prior CMC filing experience. * 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
Director/Sr. Director/VP, Biologics Manufacturing Science & Technology This is an exciting foreign expatriate leadership opportunity responsible for leading all Manufacturing Sciences & Technology (MSAT) operations for large scale commercial manufacturing for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity. You will be charged with overseeing the following activities: * Leading a 100+ person MSAT organization comprised of upstream cell culture and downstream purification manufacturing operations teams including MSAT Directors, Managers and Supervisors. * Providing technical and organizational leadership relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead downstream related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Serving as a technical/scientific Subject Matter Expert for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery. * Serving as a technical/scientific Subject Matter Expert for upstream cell culture/fermentation activities ranging from vial thaw, inoculum, media development, media optimization, cell line development and stainless steel bioreactor operations. * Managing organizational laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Managing organizational technology transfer processes including the authoring of tech transfer documentation including PCS, GAP reports, Process FMEA, Campaign Summaries and Process Validation documents. * Interfacing and engaging with global BioPharma clients and partners throughout Business Development, Product Lifecycle and Technology Transfer projects. * Driving programs and initiatives driving plant operational excellence, Six Sigma and lean manufacturing. * Ensuring all plant safety policies and procedures are met in compliance with internal and external regulatory standards. Desired Skills: * BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 10-15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Strong team leadership overseeing large Upstream and Downstream MSAT organizations and teams. * Strong Scientific and Engineering technical experience performing downstream protein purification manufacturing activities involving column chromatography, filtration (UF, DF, TFF), harvest and recovery for the manufacturing of recombinant protein and monoclonal antibodies. * Strong Scientific and Engineering technical experience performing upstream mammalian cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development and stainless steel bioreactor operations. * Experience leading projects relating to process validation, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes within cGMP, FDA and EMA compliance. * Expertise involving Plant Operational Excellence, QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, Lean Manufacturing and Six Sigma methodologies. * 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
Senior Director, Analytical Development This is a stellar opportunity responsible for leading Analytical Development activities within a Clinical Development CDMO organization working on the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CDMO/CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Leading a team of Scientists performing analytical development activities for the characterization of complex monoclonal antibodies including Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques. * Leading analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance. * Leading technology transfer processes and working cross functionally with Quality Control departments. * Designing and conducting stability, impurity and degradation studies. * Leading analytical related process characterization studies. * Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions. * Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Cell Lined Development, Process Development, Manufacturing, MSAT, Regulatory, Quality Assurance and Quality Control departments. Desired Skills: * MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Protein Analytical expertise developing methods for the characterization of complex monoclonal antibodies including Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. * Experience leading large teams of Scientists performing Analytical Development and Methods Transfer activities for BioPharmaceutical Development and Manufacturing. * Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques. * Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Experience working on technology transfer and validation activities within cGMP compliance. * 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
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/	San Francisco, CA
Director/Head, ADC Manufacturing Business Operations This is a stellar opportunity charged with starting up and leading Technical and Business Operations for 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 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and new ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Driving and leading the overall ADC business operations including team management, project execution and business delivery including the setting of business goals, resources and budgets. * Driving the startup of ADC plant operations including process development, GMP facility management, process development, scale-up, tech transfer into manufacturing and supply chain operations. * Providing team leadership, mentoring and overall team oversight for process development and production operations teams. * Leading the development & optimization of highly sensitive ADC conjugation processes ensuring quality and safety. * Providing input on payload handling procedures and for facility design from a human safety perspective. * Developing and incorporating site-specific antibody conjugation platform technologies. * Supporting the standardization of processes and communications to build efficiency within cross-functional teams. * Partnering directly with Business Development teams serving as ADC SME and engaging with prospective clients. * Providing input for facility process design, equipment validation and equipment selection. * Providing support for GMP document generation including SOPs and batch records. * Leading and supporting technical process clarification with clients. * Supporting FDA/EMA quality audits and global regulatory inspections. Desired Skills: * 10-15+ years working experience with ADC biopharmaceuticals, including manufacturing process development. * MS or Ph.D. in Biochemistry, Biology, Organic Chemistry, Chemistry, or related Biological Sciences degree. MBA or Advanced Business Degree a plus. * Proven technical experience with ADC conjugation processes, tech transfer and manufacturing operations for commercial ADCs and monoclonal antibody therapeutics. * Financial and Business Operations experience managing P&Ls, complex budgets and financial resources. * Experience managing ADC safety operations including the safe handling of cytotoxic payload compounds as well as adhering to proper EHS standards. * Project Management leadership experiences as well as Lean Six Sigma experience. * Experience contributing to CMC, IND and BLA regulatory filings and submissions with the FDA and EMA. * 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/Director, Upstream Process Development This is a stellar opportunity responsible for leading upstream mammalian cell culture process development and tech transfer activities for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Leading the development and implementation of upstream cell culture processes from bench scale, scale-up, pilot scale, technology transfer through to clinical manufacturing. * Providing technical leadership for developing, optimizing, scaling-up, and validating steps in upstream process development for the generation of complex monoclonal antibodies, ADC?s, Bispecific Antibodies and Fusion Proteins. * Serving as the technical project lead for the development of robust high performing upstream processes with emphasis on transferability to cGMP manufacturing. * Overseeing cell culture-specific project plans, including raw materials and equipment availability, in preparation for laboratory and pilot scale runs. * Serving as technical lead for client development projects, communicating project updates and providing technical explanations and rationalization. * Serving as technical project lead driving the development and implementation of processes from bench to scale-up, including technology transfer through clinical GMP manufacturing. * Working collaboratively with internal staff to generate project and cost proposals, timelines, and work plans by applying scientific knowledge and business expertise. Desired Skills: * 8+ years of Biotechnology industry experience leading upstream mammalian cell culture process development. * MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field. * Upstream mammalian cell culture process development experience for the generation of complex monoclonal antibodies including ADC?s, Bispecific Antibodies or Fusion Proteins. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations for the manufacturing of recombinant proteins, monoclonal antibodies, ADCs or mRNA vaccines. * Subject matter expert in process development areas including high throughput technologies, Ambr bioreactors, technology transfer, scale-up of processes to pilot and manufacturing scales. * Experience leading cross-functional, multi-national teams including tech transfer teams. * Excellent understanding and working knowledge of cGMP and biopharmaceutical product development lifecycles and regulatory filings (BLA, MAA, IND). * Ability to build and maintain strong, positive relationships with customers. * 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/	Princeton, NJ
Downstream Process Engineer II 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