Sr Scientist, Analytical Development – Novel DPP1
Insmed · Research Development Lab, NJ
CMCFull-time$127k–$166kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Insmed seeks a Senior Scientist in Analytical Development to lead method development and validation for small-molecule drug substances and products across early- to late-stage programs. The role supports regulatory compliance and technology transfer while collaborating across cross-functional teams in the Bridgewater, NJ office.
What they're looking for
- Bachelor's degree in chemistry, biochemistry, or related field with 6+ years experience; or master's degree with 4+ years experience
- Hands-on expertise in analytical testing for inhalation, solid oral, and liquid dosage forms
- Proficiency in HPLC, GC, LC-MS, NMR, UV, and FTIR analytical techniques
- Strong knowledge of regulatory requirements including cGxP, CMC, ICH, and compendial standards
- Advanced proficiency in Microsoft Office tools
- Experience with inhalation and combination products preferred
What you'll be doing
- Lead development and optimization of analytical methods for drug substances, intermediates, and products
- Design and execute method validation activities in compliance with ICH, FDA, EMA, and regulatory guidelines
- Oversee method transfer to manufacturing and quality laboratories with comprehensive documentation
- Author and review analytical sections of regulatory submissions including IND, IMPD, and NDA/MAA
- Serve as analytical lead for CMC programs, managing deliverables and external service providers
Privacy & handoff
This role links to Insmed's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.