Biologics Analytics Lead - Principal Scientist II

University of Georgia- FACS; Waltham, Northern (MA, KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

AbbVie seeks a Principal Scientist II to lead the Analytical Development team within Biologics. This role focuses on advancing late-stage programs with a strong analytical background and cross-functional leadership across CMC, R&D, and regulatory interactions.

You will mentor scientists, drive method development for separation-based analyses (HPLC, capillary electrophoresis), and guide high-throughput assays while supporting IND/BLA filings. Strong communication and collaboration are essential.

Qualifications

• PhD with 8+ years of biotech/pharma experience.
• Experience leading analytical development for late-stage biologics (mAbs, ADCs, fusion proteins).
• Expertise in separation-based analytics (HPLC, capillary electrophoresis); MS/ELISA is a plus.
• Strong technical writing for regulatory submissions and agency responses.

Responsibilities

• Lead and mentor scientists in separation-based assays for biologics development.
• Serve as process analytics lead for mab and DS in CMC teams; partner with process development.
• Act as SME for separation-based methods; support method development and troubleshooting.
• Evaluate analytical technologies; support automation and high-throughput methods.
• Prepare and review technical documents for IND/BLA filings and regulatory inquiries.
• Collaborate with R&D and PDS&T on program transitions and alignment.
• Communicate project strategies, issues, and risks to relevant teams.
• Demonstrate scientific excellence and implement novel analytical techniques.

Skills

People leadership

Communication

Cross-functional collaboration

Analytical thinking

Problem solving

Project management

Adaptability

Education

PhD in chemistry/biochemistry/biological engineering

Tools

HPLC

Capillary electrophoresis

Mass spectrometry

ELISA

Job description

AbbVie seeks a Principal Scientist II to lead the Analytical Development team within Biologics. This role focuses on advancing late-stage programs with a strong analytical background and cross-functional leadership across CMC, R&D, and regulatory interactions.

You will mentor scientists, drive method development for separation-based analyses (HPLC, capillary electrophoresis), and guide high-throughput assays while supporting IND/BLA filings. Strong communication and collaboration are essential.