The analytical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other therapeutic biologic medicines by developing analytical methods and providing analytical results to support drug substance and drug product process and formulation development.
We are looking for a highly motivated person who can oversee laboratory activities supporting analytical development of new biologics from FIH through registration. The candidate will lead a group of motivated scientists in method development, method validation, release and stability testing of new biologic development compounds and provide key data for regulatory submissions. The candidate will serve as the analytical representative on the CMC team for early development programs and as such would be responsible for developing timelines and executing analytical activities required for drug substance and drug product development. The candidate must be able to mentor and develop staff with novel experimental approaches to answer difficult scientific questions. Working closely with formulation and process development scientists, the candidate will develop productive collaborations and communications with scientific teams.
- Lead activities associated with analytical characterization for new biologic compounds, including assessment of process/formulation development samples and clinical trial supplies, (e.g. GMP compliant release and stability testing).
- Lead the design and execution of experiments for method validation studies.
- Lead analytical strategy development for FIH programs.
- Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting equipment and experimental problems.
- Author and review key regulatory documents, laboratory data, technical memos and reports.
- Encourage ideas for continuous improvement activities and initiatives within work group.
- Understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.
- BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry, Biochemistry, or Biology with 8+ years of previous work experience in a pharmaceutical laboratory setting.
- Experience in analytical methodology (HPLC, KF, UV-Vis, compendial tests and KF). Experience in bioanalytical techniques including SEC, CEX, CE-SDS, icIEF, ELISA, and subvisible particle analysis for parenteral drug products is preferred.
- Previous supervisory experience required (2+ years).
- Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies. Experience in ELN preferred.
Key AbbVie Competencies:
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced