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
The MSAT Specialist (Downstream) is part of the team responsible for Process Transfer, Process Validation and Operational Excellence that support GMP cell culture manufacturing operations, Develops new technologies/equipment, and implements new systems, process improvements, equipment and procedures.
- Participate as MSAT representative on client project teams.
- Lead activities to transfer processes to Manufacturing from internal AGC Process Development at other sites or directly from customers, including driving the drafting and revising manufacturing batch records.
- Perform manufacturability assessments for new process introductions.
- 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.
- Serve as the key project designee responsible for identifying new technologies set to improve manufacturing capabilities.
- Maintain and report process run summaries and continued process verification reports.
- Prepare and present data associated with manufacturing processes to internal and external clients.
- Support for process validation preparation, execution, and reporting.
- Maintenance of Process Control Strategy.
- Work with clients on process mapping and scale-up of manufacturing processes.
- Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- 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 Process Development, Engineering, QA, QC, etc.).
- Proven experience successfully managing multiple projects simultaneously.
- 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.
- Ability to provide technical training to others on GMP manufacturing operations.
- Strong communication skills necessary to interact with internal stakeholders.
- Strong presentation skills.
- Expertise in relevant math, science and engineering disciplines.
- Expertise in Cell Culture from thaw to API fill.
- Expertise in Disc-Stack centrifugation.
- Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function.
- BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred.
- 3+ years’ relevant experience from the pharmaceutical industry working in a cGMP environment.
- Advantage with relevant 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.
- Advanced computer skills including Excel and Word.
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.