Senior Scientist, Analytical Development - Large Molecule

Insmed · Research Development Lab, NJ

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CMCFull-time$127k–$166kCompany career page

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Role summary

Insmed seeks a Senior Scientist in Analytical Development for large molecule biologics to lead method development, validation, and characterization activities supporting preclinical and clinical drug candidates. The role involves managing internal analytical capabilities and overseeing external testing at contract partners while serving as a subject matter expert for protein therapeutics.

What they're looking for

PhD with 2+ years biopharmaceutical industry experience, or Master's with 4+ years, or Bachelor's with 6+ years
Advanced expertise in bioanalytical chemistry and analytical method development
Hands-on experience with chromatography (HPLC, UPLC, GC) and mass spectrometry (LC-MS, MS/MS) techniques
Strong understanding of pharmaceutical development process from preclinical through lifecycle management
Knowledge of GxP, ICH, and compendial (USP/EP/JP) regulatory requirements
Strong statistical skills with ability to design experiments and draw valid conclusions
Demonstrated capability to manage and communicate technical data across multidisciplinary teams

What you'll be doing

Lead development, optimization, and qualification of analytical methods for biologics R&D projects using advanced techniques
Manage internal analytical laboratory and oversee analytical activities at CROs and CDMOs
Design and execute experiments characterizing biochemical and biophysical properties of protein therapeutics
Author analytical sections of regulatory submissions (INDs, CTAs, BLAs) and support health authority interactions
Collaborate with internal teams and external vendors on method development, stability testing, and technology evaluation

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