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 and cell and gene therapies. 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 an Associate MSAT Specialist/MSAT Specialist/Sr MSAT Specialist to join the Downstream Technical Services group in Manufacturing Science and Technology (MSAT) team at AGC Biologics. This position requires technical problem-solving and inter-departmental collaboration. The MSAT team is responsible for the transfer, validation, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.
- Serve as MSAT representative on client project teams.
- Actively support/lead process optimization and implementation of strategies for improving Downstream unit operations throughout the product lifecycle.
- Support/Lead resolution of deviations, investigations, and process issues.
- Network with Process Development, Manufacturing, and Quality team members to ensure reliable state to process control, and drive continuous improvements.
- Participate/lead in review and analysis of manufacturing campaign data trending, and present daily progress, as well as end of campaign summary updates.
- Support/ lead emergent events response for on-floor manufacturing issues.
- Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
- Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
- Provide technical leadership to Manufacturing and other departments associated with GMP operations.
- Serve as the process Subject Matter Expert; provide input 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.
- Prepare and present data associated with manufacturing processes to internal and external clients.
- Maintenance of Process Control Strategy
- Process training, as needed, in adherence to company policies and quality requirements.
KNOWLEDGE, SKILLS & ABILITIES:
- Working knowledge of Downstream unit operations.
- Well-experienced with operations of single-use technologies and aseptic processing.
- Must be self-motivated, organized and proactive.
- Demonstrated ability to interface/communicate extensively with internal and external clients.
- Ability to coordinate multi-departmental tasks and deliverables (interaction with Manufacturing, Process Development, Engineering, QA, QC, etc.).
- Proven experience successfully managing multiple projects simultaneously.
- Demonstrated ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management and Business Development) to support processes and products.
- Demonstrated experience leading troubleshooting efforts.
- Ability to provide technical training to others on GMP manufacturing operations.
- Strong communication skills necessary to interact with internal stakeholders.
- Strong presentation skills.
- Bachelor’s Degree in Engineering or Science-related field and 10+ years of experience.
- Master’s Degree in Engineering or Science-related field and 2+ years of experience, or
- PhD or equivalent and 0-2+ ears of experience, may include postdoc experience. Equivalent education and experience may substitute for stated requirements.
- 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.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.