Principal Research Scientist II, Analytical Lead, R&D
AbbVie
19 days ago
On-site
San Francisco, CA
$141,500 - $268,500 USD yearly
Clinical Research and Development
Role Summary
- Own analytical development strategy and deliverables for assigned biologic programs; primary analytical point of contact for CMC development.
- Coordinate method development, validation, transfer, and clinical supply testing across internal labs, Quality Control, and external contract labs.
Responsibilities
- Conceive and own analytical development strategy (methods, specifications, CQAs, stability plans, extended characterization, comparability).
- Translate strategy into scoped work packages for internal teams; deliver work on time to meet CMC objectives.
- Manage third-party lab execution (quality and timelines).
- Interpret trends across release, stability, and characterization assays.
- Partner with process/drug product development on analytical strategies for process and formulation studies.
- Author/review regulatory submission documents, health authority responses, technical reports, lab data, and method validation protocols/reports.
- Communicate strategy, risks, and issues; present updates; plan resources/budget.
- Mentor dual-role analytical leads; serve as SME; compile consolidated analytical reporting.
Qualifications & Skills
- Degree in Chemistry/Biochemistry/Analytical Chemistry (PhD 8+ yrs, MS 14+ yrs, or BS 16+ yrs relevant industry experience).
- Expertise in release/stability/extended characterization methods for protein therapeutics (e.g., HPLC, CE, MS, potency, ELISA, cell-based assays, CD, DSC, light scattering).
- Project management for analytical development of biologics (multi-specifics, mAbs, ADCs, fusion proteins).
- Experience with INDs/IMPDs and change records/exception reports/investigations in GXP.
- Knowledge of ICH/FDA/EMA requirements; DoE/stability trending; JMP or similar; self-motivated, detail-oriented problem solver.
Benefits (if applicable)
- Paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
- Own analytical development strategy and deliverables for assigned biologic programs; primary analytical point of contact for CMC development.
- Coordinate method development, validation, transfer, and clinical supply testing across internal labs, Quality Control, and external contract labs.
Responsibilities
- Conceive and own analytical development strategy (methods, specifications, CQAs, stability plans, extended characterization, comparability).
- Translate strategy into scoped work packages for internal teams; deliver work on time to meet CMC objectives.
- Manage third-party lab execution (quality and timelines).
- Interpret trends across release, stability, and characterization assays.
- Partner with process/drug product development on analytical strategies for process and formulation studies.
- Author/review regulatory submission documents, health authority responses, technical reports, lab data, and method validation protocols/reports.
- Communicate strategy, risks, and issues; present updates; plan resources/budget.
- Mentor dual-role analytical leads; serve as SME; compile consolidated analytical reporting.
Qualifications & Skills
- Degree in Chemistry/Biochemistry/Analytical Chemistry (PhD 8+ yrs, MS 14+ yrs, or BS 16+ yrs relevant industry experience).
- Expertise in release/stability/extended characterization methods for protein therapeutics (e.g., HPLC, CE, MS, potency, ELISA, cell-based assays, CD, DSC, light scattering).
- Project management for analytical development of biologics (multi-specifics, mAbs, ADCs, fusion proteins).
- Experience with INDs/IMPDs and change records/exception reports/investigations in GXP.
- Knowledge of ICH/FDA/EMA requirements; DoE/stability trending; JMP or similar; self-motivated, detail-oriented problem solver.
Benefits (if applicable)
- Paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.