Senior Scientist, Analytical Development (Large Molecule)

About the role

We're seeking a Senior Scientist, Analytical Development (Large Molecule) to join our Analytical Development team. Reporting to the Senior Manager, Large Molecule Analytical Development, you'll manage the internal analytical laboratory and oversee analytical activities at CROs/CDMOs. Key responsibilities include method development, qualification/validation, method transfer, and characterization of drug substances and drug products.

Responsibilities

• Lead method development, analytical testing, and method qualification initiatives.
• Develop and implement methodologies for quantitation, characterization, and stability testing of drug substances and drug products.
• Manage authoring of analytical sections in INDs, CTAs, BLAs, and regulatory interactions.
• Collaborate with internal partners, CROs, and contract laboratories on method development, stability testing, and technical transfer documents.
• Present scientific results to cross-functional teams and serve as the analytical development SME for large molecules.

Requirements

• B.S. in Chemistry or Biochemistry with 8+ years of experience, M.S. with 6+ years, or PhD with 3+ years in the biopharmaceutical industry.
• Hands-on experience with various analytical techniques including chromatography, mass spectrometry, and electrophoresis.
• Strong statistical skills and understanding of GxP, CMC, ICH, and compendial regulations.
• Excellent presentation and writing skills.
• Proficiency in Microsoft Office and organizational skills.

Qualifications

• Ability to define problems, collect data, and draw valid conclusions.
• Experience with SEC-MALS, MS, and bioanalytical methods.
• Knowledge of laboratory safety and quality control practices.

Skills

• Expertise in chromatography (HPLC, UPLC, SEC), electrophoresis, ELISA, and other standard methodologies.
• Experience with ELISA, SPR, BLI, and cell-based assays.
• Knowledge of half-life extension methods such as PASylation and PEGylation.
• Ability to manage authoring of analytical sections in regulatory documents.

Benefits

Life at Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules. Additionally, we offer a 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).

Pay

$127,000.00 - $165,500.00 Annual

Schedule

This role is based in our Bridgewater, NJ office and requires full-time, in-person presence. Minimal travel is expected.