Principal Scientist I, Biologics Analytical R&D (External Programs)
AbbVie
June 26, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Clinical Research and Development
Overview:
Analytical Development – External Programs group responsible for early development programs (through clinical proof of concept) with outsourced analytical activities. Serve as analytical lead on internal CMC teams and work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies. Define analytical strategies for formulation and process development studies. Key deliverables include robust analytical methods, clinical supplies release testing and stability studies (clinical product dating), product control strategies, comprehensive data packages, and regulatory submission content.
Major Responsibilities:
- Develop analytical strategies and communicate to Analytical R&D/CMC partners for execution supporting stability studies, product analytical control strategies, comparability studies, and extended characterization of biologics.
- Collaborate with third-party laboratories to meet CMC timelines.
- Interpret data trends in key analytical release and stability assays.
- Author and/or review regulatory documents, laboratory data, technical memos, and reports.
- Advise peers/senior management; mentor peers on project management and analytical strategy development.
- Demonstrate scientific excellence and build consortia collaboration networks.
- Lead/participate in continuous improvement initiatives.
- Adhere to code of conduct, safety, and GXP compliance.
Qualifications:
- MS (12+ years) or PhD (6+ years) in Chemistry, Biochemistry, or Biology; 6+ years pharma lab experience.
- Preferred: project management/leadership experience for analytical development of biologics (mAbs, ADCs, and/or fusion proteins).
- Strong knowledge of protein HPLC (SEC, IEX, HIC), capillary electrophoresis, and other protein separation techniques.
- Demonstrated scientific writing and excellent verbal communication.
- Preferred: LIMS, CDS, ELN experience.
- Preferred: statistical knowledge (capability analysis, gauge R&R, DOE).
Benefits (if applicable to this role):
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.
Application instructions:
- None stated.
Analytical Development – External Programs group responsible for early development programs (through clinical proof of concept) with outsourced analytical activities. Serve as analytical lead on internal CMC teams and work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies. Define analytical strategies for formulation and process development studies. Key deliverables include robust analytical methods, clinical supplies release testing and stability studies (clinical product dating), product control strategies, comprehensive data packages, and regulatory submission content.
Major Responsibilities:
- Develop analytical strategies and communicate to Analytical R&D/CMC partners for execution supporting stability studies, product analytical control strategies, comparability studies, and extended characterization of biologics.
- Collaborate with third-party laboratories to meet CMC timelines.
- Interpret data trends in key analytical release and stability assays.
- Author and/or review regulatory documents, laboratory data, technical memos, and reports.
- Advise peers/senior management; mentor peers on project management and analytical strategy development.
- Demonstrate scientific excellence and build consortia collaboration networks.
- Lead/participate in continuous improvement initiatives.
- Adhere to code of conduct, safety, and GXP compliance.
Qualifications:
- MS (12+ years) or PhD (6+ years) in Chemistry, Biochemistry, or Biology; 6+ years pharma lab experience.
- Preferred: project management/leadership experience for analytical development of biologics (mAbs, ADCs, and/or fusion proteins).
- Strong knowledge of protein HPLC (SEC, IEX, HIC), capillary electrophoresis, and other protein separation techniques.
- Demonstrated scientific writing and excellent verbal communication.
- Preferred: LIMS, CDS, ELN experience.
- Preferred: statistical knowledge (capability analysis, gauge R&R, DOE).
Benefits (if applicable to this role):
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.
Application instructions:
- None stated.