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 are looking for an experienced Quality Control Scientist II – Project Management to join the AGC Biologics team. This scientist will represent QC on project teams for clinical and commercial products with primary responsibility for method transfer and validation of Drug Substance release assays. Working with QA, Manufacturing and Analytical Development groups, the QC Scientist will be responsible for completion of milestones for method transfer, test method authoring, and specification development.
A strong background in method development, qualification and validation is highly desired. A background in Quality Control testing related to Biopharmaceuticals is required.
- Represent QC on teams, prepare and present data to internal and external clients
- Design and author method transfer and validation studies, analyze and resulting data, author and review protocol and reports, in support regulatory submissions
- Author sample plans, test methods, and specifications to support in-process and drug substance release testing
- Highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
- Contribute to laboratory investigations, deviations, CAPAs and analytical troubleshooting
- Act as subject matter expert for QC GMP operations during audits and regulatory inspections
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong knowledge and experience of cGMP and the regulatory requirements for biopharmaceutical QC testing
- Excellent analytical, technical writing, communication and data management skills
- Contribute expertise in analytical methods across a wide range of technologies for the analysis of peptides/ proteins
- Ability to understand analytical/technical data
- Clear, concise writing skills
- Ability to interact constructively with co-workers
EDUCATION / EXPERIENCE:
- Education: Minimum BS, but preferably an advanced degree in Chemistry, Biochemistry or other Biological Science
- Experience: Minimum of 8 years’ hands-on experience with Quality Control testing, such as HPLC, CE-SDS, or ELISA in a regulated environment (GMP, GLP, etc.). Minimum of 2 years’ experience with a PhD.
- Experience with relevant analytical laboratory instruments and software
$97,917 - $117,500 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.