Principal Scientist I, Biologics Analytical R&D (External Programs)
AbbVie
August 08, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Clinical Research and Development
Overview:
AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities for AbbVie's therapeutic biologic products. The Analytical Development – External Programs group is responsible for early development (through clinical proof of concept) of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies.
Major Responsibilities:
- Develop analytical strategies and communicate them for experimental execution in support of stability studies, product analytical control strategies, comparability studies, and extended characterization of biologics.
- Collaborate with third-party laboratories to meet CMC timelines.
- Interpret and identify data trends in key analytical release and stability assays.
- Author and/or review regulatory documents, laboratory data, technical memos, and reports.
- Advise peers and senior management; mentor peers in project management and analytical strategy development.
- Demonstrate scientific excellence; build consortia collaboration network.
- Lead/participate in continuous improvement initiatives.
- Adhere to corporate code of conduct, safety, and GXP compliance.
Qualifications:
- MS (12+ years) or PhD (6+ years) in Chemistry, Biochemistry, or Biology; 6+ years pharmaceutical laboratory experience.
- Preferred: project management/leadership in analytical development for biologics (mAbs, ADCs, and/or fusion proteins).
- Experience/knowledge: protein HPLC (SEC, IEX, HIC), capillary electrophoresis, and other protein separation techniques.
- Scientific writing and verbal communication skills.
- Preferred: LIMS, CDS, ELN; statistical knowledge (capability analysis, gauge R&R, DOE).
AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities for AbbVie's therapeutic biologic products. The Analytical Development – External Programs group is responsible for early development (through clinical proof of concept) of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies.
Major Responsibilities:
- Develop analytical strategies and communicate them for experimental execution in support of stability studies, product analytical control strategies, comparability studies, and extended characterization of biologics.
- Collaborate with third-party laboratories to meet CMC timelines.
- Interpret and identify data trends in key analytical release and stability assays.
- Author and/or review regulatory documents, laboratory data, technical memos, and reports.
- Advise peers and senior management; mentor peers in project management and analytical strategy development.
- Demonstrate scientific excellence; build consortia collaboration network.
- Lead/participate in continuous improvement initiatives.
- Adhere to corporate code of conduct, safety, and GXP compliance.
Qualifications:
- MS (12+ years) or PhD (6+ years) in Chemistry, Biochemistry, or Biology; 6+ years pharmaceutical laboratory experience.
- Preferred: project management/leadership in analytical development for biologics (mAbs, ADCs, and/or fusion proteins).
- Experience/knowledge: protein HPLC (SEC, IEX, HIC), capillary electrophoresis, and other protein separation techniques.
- Scientific writing and verbal communication skills.
- Preferred: LIMS, CDS, ELN; statistical knowledge (capability analysis, gauge R&R, DOE).