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 Quality Control Microbiology Scientist will provide technical and compliance leadership related to microbiological assays, environmental monitoring, facility qualification, and GMP quality systems within the Quality Control department. The individual in this role will also review data, author reports, design cleaning verification studies, and support laboratory instrument validation. The ideal candidate will have extensive experience in biopharmaceutical microbiology, GMP compliance, environmental and utility monitoring, and strong organizational skills. This position may oversee QC analysts as a team lead or supervisor.
- Perform and oversee product and facility testing related to microbiological assays, review data and interpret and report results.
- Act as subject matter expert on microbiological assays, method qualification, technical troubleshooting, and instrument validation.
- Design and execute cleaning verification studies and oversee related equipment and utility qualification activities.
- Author, review and approve procedures, specifications, and validation documents.
- Represent QC Microbiology on cross-functional teams and prepare and present data to internal and external clients.
- Implement change controls, lead investigations, and complete CAPAs in support of GMP operations.
- This position will support and provide oversight in preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
KNOWLEDGE, SKILLS & ABILITIES:
- Requires knowledge of environmental and utility monitoring program design, compendial microbiological testing (bioburden, endotoxin), TOC and conductivity testing, investigations and report writing.
- Experience with laboratory software and data management systems such as LIMS, DataPro2, and/or Endoscan.
- Strong organizational skills in a high-throughput environment.
- Excellent communication and verbal presentation skills.
- Education: Minimum BS in Biology, Microbiology, or other scientific discipline.
- Minimum of 5+ years hands-on experience in a GMP Quality Control laboratory.
- Strong understanding of Microbiology related to drug substance, utility, and facility testing.
- Experience with relevant analytical laboratory equipment and software.
- Experience with GMP biologics manufacturing and related regulatory requirements including USP and EP compendial testing.
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.