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 Scientist, Biochemistry will perform routine and more complex tasks in the Quality Control laboratory, including testing of in-process, release, and stability samples, execution of method transfer and validation studies, and instrument qualification. The ideal candidate will have extensive experience in a GMP laboratory, strong technical writing skills, and proficiency with HPLC, CE-SDS, ELISA and other biopharmaceutical analytical techniques.
- Perform in-process, release and stability testing of biopharmaceutical test samples in a GMP QC laboratory using a wide variety of technologies, including HPLC/UPLC, capillary electrophoresis (CE-SDS and icIEF), ELISA, and cell-based bioassays.
- Execute method transfer and validation studies, develop data processing and report templates, and troubleshoot assays and instruments.
- Author, review and approve test methods, procedures, specifications, and validation documents.
- Assist in the onboarding and qualification of new laboratory instruments. Author user requirement specifications, IOQ protocols, data integrity risk assessments, and operation and maintenance.
- Mentor and train analysts on test methods and laboratory procedures, good documentation practices, data review, and other QC quality systems.
- Lead change controls, investigations, and CAPAs in support of GMP operations. Drive Quality deliverables to closure by agreed upon due dates.
- Represent QC during client audits and regulatory inspections. Maintain the QC laboratory in an inspection ready state.
KNOWLEDGE, SKILLS & ABILITIES:
- Extensive experience with biopharmaceutical analytical techniques such as HPLC, CE-SDS, ELISA, bioassay, and/or compendial testing.
- Experience with GMP laboratory data systems, including LIMS, Empower, SoftMax Pro, or other analytical systems.
- Knowledge of FDA and ICH requirements for method transfer, validation, data integrity, and compendial verification.
- Demonstrated ability to work effectively on cross-functional teams, including with Analytical Development, Quality Assurance, Manufacturing, and Validation personnel.
- Strong organizational and project management skills, including technical writing and presentation of technical data.
- Education: Minimum BS in Biochemistry, Biology or other scientific discipline.
- Experience: Minimum of 5+ years hands-on experience in a GMP laboratory environment, preferably in the biopharmaceutical industry.
- Trained in fundamental GMP quality systems, including good documentation practices, data integrity, change management, and laboratory controls.
- Experience with the design, operation, validation, and maintenance of complex laboratory equipment and software systems.
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.