AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
We have an opportunity for a Manager/Senior Manager of Downstream Tech Transfer to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics. This team member will lead the effort of Technology Transfer activities with a product lifecycle concept for manufacturing process. This is a key leadership position in the MSAT team that is responsible for process transfers and technology implementation throughput the product life cycle for our product portfolio. The MSAT team is responsible for the transfer, validation, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.
PRINCIPAL RESPONSIBILITIES INCLUDE:
Directs and controls activities of the department including all people management activities such as establishment of strategic plan, effective delivery of objectives and KPI, project resourcing, mentoring, training, goal setting, and performance evaluation. Also develop and improve the efficiency of the department by setting up the department structure and updating procedures to meet the needs of the clients.
Design and lead execution of risk assessments that are compliant with company’s validation program and aligned with industry’s best practices.
Review/author relevant technical sections of regulatory dossier or other communications to health authorities, as well as, provide leadership in support of inspections/audits.
Act as Investigation Lead in deviation investigations and change control.
Act as Technical lead in leading team to transfer processes and technologies from Process Development to Manufacturing, in accordance with Tech Transfer Plan and New Product Introduction.
As subject matter expert (SME), participate in project evaluations against technical requirements, as well as, leadership/ representation in CMC-related governance meetings. May support Business Develop for potential client presentations and proposal generation.
Improve alignment of Technology Transfer activities globally, together with MSAT leaders at our other sites.
Interface with the project teams to support product life cycle change management projects, including drive long-term process improvements execution.
Provide technical leadership to Manufacturing and other departments associated with GMP operations.
Lead MSAT team in supporting manufacturing when troubleshooting processes on the manufacturing floor and during post-operational investigations
Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
Lead cross-site initiatives, ensuring seamless cross-organizational interactions.
The position offer interaction with a large number of internal stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.
KNOWLEDGE, SKILLS AND ABILITIES:
Experience mentoring and developing high performing teams.
Must be self-motivated, organized and proactive.
Ability to work on complex issues where analysis of situations or data requires in depth knowledge of the company objective.
Demonstrated ability to interface/communicate extensively with internal and external clients, including senior management on matters concerning several functional areas, divisions, and/or customers.
Ability to coordinate multi-departmental tasks and deliverables (interaction with Business Development, Process Development, Manufacturing, Engineering, Quality, etc.).
Prior experience managing technical staff in a GMP environment
Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
Demonstrated experience leading troubleshooting efforts.
Strong communication skills necessary to interact with internal and external stakeholders, with an ability to obtain buy-in from all key stakeholders.
Strong presentation skills.
Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.
EDUCATION / EXPERIENCE:
Bachelor’s Degree in Engineering or Science-related field.
Minimum of 2 years primary biotechnology cell culture and/or recovery and purification experience, preferably in clinical/commercial GMP manufacturing.
Minimum of 2 years of experience bringing biotechnology equipment and processes from design through GMP operational readiness.
Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
Must have experience writing, reviewing and approving GMP documentation.
Hiring will commensurate with experience. AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.