Lead Scientist, Biologics Analytics & CMC Strategy

BioSpace; North Chicago (IL); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Medical/dental/vision insurance

Job summary

AbbVie Biologics ARD seeks an analytical lead to drive CMC analytical activities for biologics programs, including mAbs and ADCs. You will partner with internal teams and external labs to develop, transfer, and validate analytical methods and ensure timely testing of clinical supplies.

The role emphasizes strategic thinking, data interpretation, regulatory documentation, and mentoring of peers, with commensurate compensation and a comprehensive benefits package.

Qualifications

• MS (12+ years) or PhD (6+ years) in Chemistry, Biochemistry, or Biology with pharma lab experience.
• Experience leading analytical development activities for biologics (mAbs, ADCs, fusion proteins).
• Strong knowledge of protein HPLC (SEC, IEX, HIC), capillary electrophoresis and related analyses.

Responsibilities

• Develop analytical strategies and communicate with Analytical R&D and CMC partners.
• Collaborate with third-party labs to meet CMC timelines.
• Interpret data trends in release and stability assays.
• Author or review regulatory documents, memos, and reports.
• Mentor peers in project management and analytical strategy development.
• Demonstrate excellence in analytical characterization of biologics.
• Lead continuous improvement initiatives and ensure GXP compliance.

Skills

Analytical strategy

Scientific writing

Verbal communication

Project management

DOE methodologies

Statistical knowledge

Cross-functional collaboration

Biologics analytics

Education

MS in Chemistry/Biochemistry/Biology

PhD in Chemistry/Biochemistry/Biology

Tools

LIMS

CDS

ELN

Job description

AbbVie Biologics ARD seeks an analytical lead to drive CMC analytical activities for biologics programs, including mAbs and ADCs. You will partner with internal teams and external labs to develop, transfer, and validate analytical methods and ensure timely testing of clinical supplies.

The role emphasizes strategic thinking, data interpretation, regulatory documentation, and mentoring of peers, with commensurate compensation and a comprehensive benefits package.