Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control

Role Summary

Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control. Hybrid role with remote and headquarters-based work options in Watertown, MA.

Responsibilities

• Characterize biologic therapeutics using analytical techniques to explore structure–function relationships, including chromatographic methods (CEX, SEC, HILIC, etc.), mass spectrometry (peptide mapping, intact mass), capillary electrophoresis, DSC/DSF, glycosylation content measurement, ELISA, and potency assays.
• Oversee development of standard protein analysis methods through external vendors and guide transfer of analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to define scopes of work and ensure activities align with program expectations.
• Provide oversight of external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Maintain up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review, and edit SOPs, protocols, reports, and quality documentation for internal and external stakeholders.
• Authorship and review of regulatory documents for multiple countries.
• Collaborate cross-functionally with Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others.

Qualifications

• BS degree required; MS/PhD preferred.
• 10–12+ years of related biopharmaceutical industry experience, with 2+ years in late-stage development of antibody or related therapeutics.
• Hands-on experience with multiple analytical methods and specification development; troubleshooting experience with analytical methods using external vendors.
• Good knowledge of cGMP and global regulatory requirements.
• Ability to develop relationships and collaborate with cross-functional groups, including Process Development, Manufacturing, Quality, and Regulatory.
• Self-starter with ability to deliver high-quality results in a fast-paced development environment; ability to prioritize and meet tight deadlines while remaining adaptable.
• Excellent communication and interpersonal skills; ability to convey complex ideas succinctly.
• Experience in IND and BLA filings is highly desired.
• Ability to travel occasionally.

Skills

• Analytical method development and transfer
• Regulatory documentation and submissions
• Vendor management and external testing oversight
• cross-functional collaboration
• Strong written and verbal communication

Education

• Bachelor's degree required; advanced degree preferred.

Additional Requirements

• Occasional travel as needed.