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 Sr. Manager, QC Microbiology will provide leadership for GMP analytical testing for clinical and commercial products. In addition, this position will provide direction for method qualification, technology transfer activities, and specification setting associated with QC testing of the Company’s GMP products. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental relationships.
- Lead and manage activities of the Quality Control microbiology lab personnel and ensure the efficiency and effectiveness of activities related to environmental monitoring, in-process and drug substance lot release testing, new product introduction and product changeover, and cleaning validation studies.
- Assist in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
- Overseeing laboratory investigations, deviations, CAPAs and troubleshooting.
- Responsible for site Periodic and Routine Environmental Monitoring reports.
- Represent QC on teams and prepare and present data to internal and external clients.
- Hire, mentor and develop exceptional QC personnel.
- Provide knowledge and understanding of overall maintenance, calibration, and qualification of the QC laboratory analytical equipment.
- Act as subject matter expert for QC GMP operations during audits and regulatory inspections. Maintain QC microbiological laboratories and facilities in audit and inspection readiness mode.
KNOWLEDGE, SKILLS & ABILITIES:
- Ability to understand analytical/technical data.
- Clear, concise writing skills.
- Good organizational skills and attention to detail.
- Ability to interact constructively with co-workers.
- Minimum BS, but preferably an advanced degree in Microbiology or other Biological Science.
- Minimum of 12+ years hands-on experience with Quality Control Microbiology testing, such as environmental monitoring, bioburden and endotoxin, in a regulated environment (GMP, GLP, etc.).
- 5+ years of people management experience coaching employees in day-to-day performance, goal setting and career development.
- Experience with relevant analytical laboratory equipment and software.
- Equivalent education and experience may substitute for stated requirements.
$129,500 - $155,400 annually
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.