This is an exciting opportunity as a Senior Electrical Engineer within an expanding Biologics Manufacturing Organization. You will be responsible for providing technical support to the manufacturing, laboratory, and logistics buildings, focusing on troubleshooting, modifications, and improvements related to electrical systems, back-up power, sustainable projects, and management systems. Your roles and responsibilities will also include:

Key Responsibilities:

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:

This is a stellar opportunity within an established, thriving, and growing Midwest based complex 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.

* 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

Expatriate Benefits Package:

* Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits.

* Company paid apartment in South Korea.

* International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School.

* Company paid airfares to visit the US (or country of origin).

* 3 weeks of vacation time.

* Opportunity to rapidly advance your career within a Global role and gain valuable international experience.

This is an exciting new Global Expat opportunity responsible for leading multifaceted Social Media Channel and Digital Communications within the within the Global Headquarters of a Major Global Corporation in South Korea. You will be charged with planning and managing the company's Global Social Channels and Digital Content aligned with its brand and products. You will also be responsible for managing collaboration opportunities with promising online influencers and creators. Your responsibilities will also include:

* Executing new tech-based initiatives boldly and agilely, leveraging deep understanding of innovative digital techniques, media trends and data solutions to generate buzz around the company brand.

* Planning and Managing the company's Social Media Channels and Digital Communications across Global regions including APAC, the Americas, Europe, Africa and Middle East. 

* Ensuring social channels and digital content is aligned consistency with its Global brand and products.

* Planning and creating social content based on the discovery of new topics and trends.

* Executing digital media and ad performance/social monitoring strategies.

* Building and managing relationship with Global digital agencies.

* Discovering and utilizing AI based marketing tools and technologies as well as integrating AI-based technology into digital marketing strategies, content planning and content production,

* Identifying and collaborating with Global content creators as well as planning new collaboration campaigns with online digital creators, influencers and editors.

* 8+ years of industry experience in digital marketing, advertising and communications within a top tier Global brand or Global advertising agency.

* Bachelor's or Master's degree in Communications, Marketing, Business Administration, Communication Design, Fine Arts, Visual Arts, Graphic Design or related field.

* Proven experience overseeing Social Channels and Social Media workflows, processes and digital campaign management for a major Global brand.

* Strong eye for detail and the ability to maintain brand consistency across various platforms and materials

* Proficient in using Social Channel or Social Media management software, apps and tools such as Hootsuite, Sprout Social, Buffer, Agorapulse or Sendible. 

* Knowledge, understanding and enthusiasm for the automotive and mobility industries.

* Excellent communication and collaboration skills, with the ability to work effectively with Global cross-functional teams.

* Passion for staying up-to-date with the latest Social Media, Digital Marketing, AI Marketing trends, marketing strategies, and brand best practices.

Expatriate Benefits Package:

* Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits.

* Company paid apartment in South Korea.

* International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School.

* Company paid airfares to visit the US (or country of origin).

* 3 weeks of vacation time.

* Opportunity to rapidly advance your career within a Global role and gain valuable international experience.

This is an exciting new Expat opportunity responsible for leading Global Brand Management activities within the Global Headquarters of a Major Global Corporation in South Korea. You will be charged with securing the consistency of the company's global brand image and producing various content to introduce and communicate the global brand vision to customers. Additionally, you will be responsible for developing and implementing brand image strategies and guidelines, as well as creating innovative brand communication assets. Your responsibilities will also include:

* Manage and oversee the corporate brand image to be consistent across Global regions including APAC, the Americas, Europe, Africa and Middle East.

* Generate creative content to communicate the company?s vision to global customers.

* Lead Brand Image Management functions including the monitoring of the global brand image, developing a brand image training program and conducting global brand image training programs.

* Locating brand difficulties across regions and updating corporate brand image guidelines.

* Providing design feedback on marketing materials created globally.

* Leading Brand Communication functions including the development of brand image guidelines and style guides.

* Developing creative content including logos, ads and marketing materials.

* 8+ years of industry experience in graphic design, advertising, or brand communications within a top tier Global brand or advertising agency.

* Bachelor's or Master's degree in Graphic Design, Communication Design, Fine Arts, Visual Arts, Marketing or related field.

* Proven track record of developing and implementing successful style guides, brand image and communication strategies for major global brands.

* Strong eye for detail and the ability to maintain brand governance and consistency across various platforms and materials

* Proficient in using design software, such as Adobe Creative Suite (Photoshop, Illustrator, InDesign), Microsoft Office (PowerPoint, Excel), and other presentation tools.

* Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams

* Passion for staying up-to-date with the latest design trends, marketing strategies, and brand best practices

Expatriate Benefits Package:

* Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits.

* Company paid apartment in South Korea.

* International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School.

* Company paid airfares to visit the US (or country of origin).

* 3 weeks of vacation time.

* Opportunity to rapidly advance your career within a Global role and gain valuable international experience.

This is a new Expat opportunity responsible for driving the design, implementation, and evaluation of impactful talent development initiatives based within the Global Headquarters of a Major Global Corporation in South Korea. The organization is committed to developing and enriching its leadership pipeline to drive continuous improvement and sustainability. In this strategic role, you will be responsible for accelerating the leadership, skills, and impact of high-potential employees and global leaders to align with the company's mission, culture, and customer needs. Additionally, you will be charged with overseeing the following key activities:

* Design, develop and execute comprehensive talent and leadership development programs, including coaching, mentoring, and the cultivation of leadership, business acumen, and management capabilities.

* Create consistent methodologies for programs to ensure high-quality and impactful learning experiences.

* Partner with HR and regional talent leads to identify and secure nominations for high-potential employees to participate in talent development programs.

* Collaborate with subject matter experts to gather content and deliver engaging, effective learning solutions.

* Establish relationships with external vendors and learning providers to optimize Hyundai's learning initiatives.

* Monitor industry trends and best practices in learning development and recommend innovative approaches to enhance the learning experience and drive organizational success.

* Coordinate customized executive development programs, such as targeted coaching.

* Apply talent data and insights to have action-oriented conversations with stakeholders, informing strategies for the retention and development of key talent.

* Collaborate with leadership to design assessment tools and measure the impact of talent development programs.

* Analyze HR data to produce insights that can inform future talent strategy and initiatives.

* Lead Global Engagement through the delivery of in-house lectures and facilitation on corporate content to support organizational learning and development.

* Lead and manage direct communication channels with overseas HR and talent development managers to align global learning initiatives.

* BS Degree in Business Administration, Marketing, Advertising, Human Resources, Communications, Management, Economics, Psychology or related field. MBA or Masters Degree a plus.

* 8+ years of Talent Development, Talent Management or Learning Development related experience within a Global enterprise company, preferably within the Automotive, Technology, Consumer Products or related industries.

* Human Resources, Training or Learning Development Certifications such as SPHR, CPLP, CTDP or CPTD preferred.

* Prior experience leading the design and delivery of learning solutions for diverse groups of learners, particularly executive leaders and high-potential employees

* Exceptional knowledge of learning theories, instructional design methodologies, psychometric tools, and adult learning principles

* Excellent verbal and written communication skills, with the ability to present effectively across various forums and to diverse audiences.

* Experience managing learning programs and projects, including budgeting and resource allocation.

Demonstrated expertise in identifying, assessing, and managing external vendor partners.

* Exceptional facilitation skills and experience leading and managing large-scale, complex learning program design and delivery projects with various stakeholders globally.

Expatriate Benefits Package:

* Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits.

* Company paid apartment in South Korea.

* International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School.

* Company paid airfares to visit the US (or country of origin).

* 3 weeks of vacation time.

* Opportunity to rapidly advance your career within a Global role and gain valuable international experience.

This is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for managing and ensuring the highest standards of Quality Control for life-saving therapies as well as supporting the ramp up of new QC labs, performing key QC lab techniques including ELISA assays and flow cytometry platforms. You?ll also be charged with managing and leading QC team members, performing GMP Quality investigations and QC stability testing.

Your roles and responsibilities will include:

* Managing the day-to-day operations for cGMP Quality Control potency testing for cell therapy intermediates, final product and stability testing.

* Managing a laboratory team of 4-5 QC Supervisors and lab analysts supporting QC Analytical release assays for cell therapy products.

* Serving as a technical SME for the performance of potency testing including ELISA assays as well as immunoassays and cell-based potency assays.

* Serving as a technical SME for working with flow cytometry and cell counting platforms.

* Leading and supporting team members through the generation and revision of laboratory documentation including CAPA?s, Change Controls, SOP?s, protocols, deviations and laboratory investigations.

* Leading and supporting team members through GMP investigations for OOS test results and other Quality related events and implementing corrective actions.

* Leading and supporting team members through vital support to QC product stability programs, including protocol generation, execution of QC stability testing and QC stability data analysis.

* Supporting LIMS initiatives including with LabVantage systems.

* BS or MS degree in Biology, Chemistry, Biochemistry, Molecular Biology or related Life Sciences field.

* 7+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

* 3+ years of prior managerial or supervisory experience. 

* Hands-on experience working with ELISA assays as well as immunoassays or cell-based potency assays.

* Hands-on experience working with multi-color flow cytometry and cell counting platforms such as FACS.

* Expertise leading or performing QC investigations with successful experience resolving related deviations.

* Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness.

Additional Position Requirements:

* Must be able to wear appropriate lab and clean room PPE including gowning coveralls, masks and gloves.

* This is a full-time permanent position working on either a Sunday through Thursday or Tuesday through Saturday schedule.

This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.

This is an exciting opportunity to lead GxP Quality Systems within a promising Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for providing Quality Systmes oversight and support for the development and operations of a commercial scale state-of-the-art cGMP cell therapy manufacturing and laboratory facilities. Your roles and responsibilities will include:

* Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware.

* Championing Data Integrity and Computer System Validation efforts, driving improvements throughout the system lifecycle.

* Spearheading cGMP quality improvement initiatives, both on-site and in remote facilities, to elevate our standards across the board.

* Crafting and maintaining essential company documentation such as quality manuals and procedures, ensuring clarity and compliance at every step.

* Serving as the voice of Quality on cross-functional teams, providing technical guidance and expertise to drive projects forward and implement system improvements.

* BS degree in Biology, Chemistry, Biochemistry, Microbiology, Molecular Biology, Engineering, Computer Science or related Engineering or Life Sciences field.

* 5+ years of hands-on Quality Systems experience working within a Cell and Gene Therapy or Biologics manufacturing environment.

* Quality Systems proficiency working with GxP TrackWise QMS, Veeva, Labware, MODA, Empower and LabVantage or related Quality Systems.

* Experience preparing for and participating in manufacturing and laboratory regulatory inspections.

* Demonstrated proficiency in creating and utilizing inspection/testing systems, ensuring the highest standards of quality are met.

* Strong communication skills, both verbal and written, enabling effective collaboration with management and project team members.

This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.

This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion.

This is an exciting opportunity to lead Project Management and Tech Transfer related manufacturing activities for biologics manufacturing. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with the following activities:

* Managing Project schedules, timelines, project scopes and business processes with clients, including project master schedule generation and updates.

* Serving as a primary point of contact for communications between external Clients and internal teams to facilitate tech transfer projects.

 * Managing regular weekly and monthly client communications relating to forecasting, manufacturing schedules, change controls, deviations, risk assessments and mitigations.

* Overseeing Project Change Request management, including generating and managing Scope of Work (SoW), confirming contract scope and alignment, and managing change orders for additional scope of work.

* Managing Core Teams and cross-functional client communications for critical issues, including arranging and leading regular/ad-hoc meetings with associated teams.

* Providing technical leadership and subject matter expertise relating to deviations, change controls, process optimization, and technical troubleshooting.

* Working cross functionally with Process Development, Manufacturing, Quality and Regulatory departments relating to process improvements, process change controls and deviation investigations.

* BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life

Sciences/Engineering field.

* 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

* Project Management leadership experience managing tech transfer processes between client companies and CMOs.

* Experience leading projects relating to manufacturing deviations, change control, process optimization,

technical troubleshooting, and manufacturing process changes.

* Biologics manufacturing expertise manufacturing large molecule biologics including monoclonal antibodies, Antibody Drug Conjugates, fusion proteins or bispecific antibodies. Experience working within a biologics CMO/CDMO a plus.

* Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Quality, Regulatory and Engineering Services departments.

* Expertise involving QbD (Quality by Design), Lean Manufacturing and Six Sigma methodologies.

* thirty

This is an exciting leadership opportunity overseeing the Quality Control Biochemistry team and Analytical Method Transfer group within a leading Contract Manufacturing Organization (CMO). This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include:

* Providing strategic direction and leadership for the QC Biochemistry team responsible for performing and reviewing chemistry/biochemistry product tests, managing test schedules for drug substance/drug product plants, and stability studies.

* Overseeing Analytical Method Transfer including analytical method development, optimization, transfer, validation, and lifecycle management activities.

* Leading analytical method gap assessments, authoring method implementation master plans (MIMPs), and executing phase-appropriate implementation of analytical test methods for release/stability testing.

* Ensuring the establishment and monitoring of assay performance criteria.

* Managing platform methods in collaboration with CDMO partners.

* Overseeing authoring of chromatography methods, protocols, and reports.

* Leading execution of method transfer, pre-validation, and validation activities.

* Overseeing laboratory control activities, including audit/inspection response and client communication.

* Supporting deviation/CAPA/change control investigations, NCRs, OOTs, and stability protocol reviews.

* Ensuring PAI readiness, supporting BLA/CMC filings and hosting FDA/EMEA audits & inspections.

This is an exciting opportunity to direct, manage, plan, and perform internal audits including operational and compliance audits. This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include:

* Lead Audits: Serve as the lead auditor for internal audits, ensuring timely escalation of critical findings.

* Report Findings: Provide reports of audit findings, analysis and recommendation to Quality Senior Management in a timely manner in order to strengthen and improve internal control, equity, and operational performance.

* Stakeholder Engagement: Collaborate with auditees to enhance internal controls and operational efficiency.

* Audit Schedule Management: Maintain and update the annual internal audit schedules.

* Report Preparation: Prepare detailed audit reports and review audit responses.

* Continuous Improvement: Support management in continuous improvement initiatives.

* Regulatory Monitoring: Keep abreast of regulatory regulations and present updates to GMP Auditing to ensure departmental compliance.

* Inspection Support: Provide support during health authority inspections.

* Auditor Training: Conduct auditor training and certification programs.

* Electronic Systems: Utilize and update audit-related documents in the electronic inspection system.

* thirty

This is a stellar opportunity responsible for leading ADC Validation Engineering processes and serving as a SME for ADC manufacturing. 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 ADC manufacturing capabilities. You will be charged with overseeing the following activities:

* Serving as a SME for Antibody Drug Conjugate equipment validation, facility validation and cleaning processes.

* Serving as a SME for Isolator equipment qualification and containment performance assessment and verification.

* Generating and maintaining Validation Master Plans and Revalidation plans.

* Authoring and generating essential validation documents including validation protocols, validation reports and test plans to support facility startup and tech transfer of ADC products.

* Updating and generating validation policies and procedures to incorporate ADC validation practices into the site validation program.

* Implementing the site Antibody Drug Conjugate containment verification program including training of personnel, revalidation and certification processes.

* Supporting Global Regulatory Agency inspections and audits.

* 8+ years working experience with ADC biopharmaceuticals, including manufacturing process development.

* BS or MS in Biochemistry, Biology, Chemistry, Chemical Engineering, Mechanical Engineering or related Life Sciences or Engineering field.

* Solid understanding of ADC manufacturing processes and equipment and risk assessments.

* Expertise in validation for ADC manufacturing including setting up containment performance targets, verification of containment performance, cleaning requirements for ADC manufacturing and isolator qualification processes.

Understanding of ADC regulatory requirements and technical standards such as ISPE guideline for Assessing the Particulate Containment Performance of Pharmaceutical Equipment.

* Familiarity with FDA and cGMPs for ADC manufacturing.

* thirty

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 multiple Quality Center operations within the World's Largest biologics CMO with commercial mammalian cell culture Drug Substance manufacturing capacity, Antibody Drug Conjugate 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.

* 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.

* Quality Assurance leadership experiences overseeing the manufacturing of complex biologic molecules including monoclonal antibodies, ADC's, Bispecific Antibodies or Fusion Proteins.

* 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.

This is an incredible foreign expatriate position charged with leading a 10-15 person CMC Regulatory Affairs team within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine, complex large molecules and ADC manufacturing capabilities. You will be responsible for managing and supervising regulatory strategies and associated filings including clients? filing support for Drug Substances and Drug Products. You will also be responsible for performing the following activities:

* Provide leadership, supervision, and line management of the Regulatory Operation group of 10-15 people responsible for CMC regulatory affairs. 

* Manage and supervise global regulatory strategies and associated submissions and approvals, achieving regulatory milestones for clinical trials, new submissions, and life cycle management on behalf of clients. 

* Manage company licenses and certifications. 

* Review and approve CTD Quality dossier and responses to questions from regulators. 

* Ensure strict compliance with regulatory requirements and company standards for all registrations and regulatory processes. 

* Optimize the regulatory process and systems, ensuring effective processes are defined and embedded, and effective risk management with disciplined regulatory compliance. 

* Deliver regulatory policy and intelligence insights to support the company's strategic priorities. 

* Build partnerships with regulatory authorities through proactive regulatory authority engagement around the world, including the US and EU. 

* Serve as a liaison between regulatory authorities and other departments of the company. 

* Enhance team capabilities through effective coaching and talent development for group members.

* Supporting major Global Clients' regulatory filings from within a large scale biologics CMO environment.

* Interfacing with, providing observation responses and interacting directly with global regulatory agencies including the FDA and EMA.

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.

This is a stellar opportunity responsible for leading upstream mammalian cell culture process development and tech transfer activities for the generation of complex molecules including 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 cGMP 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.

* Driving process innovation initiatives including the implementation of perfusion and continuous manufacturing processes.