Scientist II, Analytical Development Specialist
2 hours ago
Absorbent and analytical expert sought to support method lifecycle activities at external laboratories for late-phase antibody-drug conjugate (ADC) development. Collaborate with cross-functional teams to enable filing and commercialization of ADC programs.
Key Responsibilities- Support validations, re-validations, transfers, continued performance verification, optimization, and troubleshooting for antibody and ADC methods established at external laboratories.
- Develop and execute phase-appropriate qualification and re-qualification of antibody and ADC reference standards, track and manage RS inventory at external laboratories, and determine forecasts and work with external organizations to fill and qualify new RS when needed.
- Author or review all documentation related to the activities above, collaborate closely with QA to ensure applicable requirements are met (GMP, ICH, compendial, etc.).
- Plan and execute laboratory experiments to support method optimization or troubleshooting.
- Author change controls for analytical-related changes and support deviation/excursion management.
- Serve as analytical representative on CMC team, work closely with manufacturing sciences, quality assurance, regulatory CMC, and supply chain to support program objectives.
- Perform statistical analysis of batch data to support specification setting and product comparability studies.
- Support Regulatory CMC activities (filings, information requests, in-country registration testing).
- BS, MS, or equivalent education in chemistry, biochemistry, or related discipline.
- At least 7 (BS) or 5 (MS) years' experience in analytical development or quality control, mostly supporting antibody or ADC therapeutics under GMP.
- Experience with analytical separation methods (HPLC, CE, etc.).
- Experience with analytical method lifecycle management (validations, transfers, CPV, etc.).
- Experience with large-molecule reference standard management.
- Strong knowledge of GMP requirements, ICH guidelines, and compendia (USP and Ph. Eur.).
- Experience working with third-party laboratories preferred.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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