Associate Director, Formulation Development
Insmed Incorporated
June 27, 2026
Remote friendly (Bridgewater, NJ)
United States
Clinical Research and Development
About The Role
We’re looking for a Formulation Scientist on the CMC Development team. You’ll lead drug product formulation development activities for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. You will also provide technical leadership and mentorship to junior scientists.
What You'll Do
- Design, develop, and optimize biologics drug product formulations (aqueous and non-aqueous)
- Develop high-concentration formulations for subcutaneous delivery
- Characterize and optimize excipient systems, buffers, and stabilization strategies; evaluate stability, aggregation, viscosity, and degradation pathways
- Conduct forced degradation and stress studies to define formulation design space
- Lead analytical characterization of biologic molecules and formulations (e.g., higher-order structure, aggregation, particle formation, colloidal behavior)
- Investigate degradation pathways, structure–function relationships, and critical quality attributes; develop/qualify/implement analytical methods for formulation screening and optimization
- Provide technical leadership for formulation strategy, candidate selection, and developability assessments
- Support late-stage activities (comparability, stability strategy, lifecycle management)
- Author/review/approve technical reports, protocols, and regulatory documentation (IND/IMPD/BLA)
- Lead/support technology transfer to internal manufacturing sites and CDMOs (formulation/characterization)
Who You Are
- PhD with 2 years’ experience in formulation development, or MS with 6 years’ experience.
You Are Or You Also Have
- Biologics drug product formulation experience (aqueous and/or non-aqueous)
- Advanced analytical techniques (chromatography, spectroscopy, light scattering, calorimetry)
- Strong biologics analytical characterization skills (SEC, DLS, DSC, spectroscopy)
- Knowledge of protein stability, degradation mechanisms, and structure–property relationships
- Experience supporting early- and late-stage development programs
Nice To Have (Not Required)
- Degree in a related field
- Mentoring/leading experience
- Fast-paced, matrixed environment experience
- CDMO/external partner hands-on experience
- Regulatory filing familiarity (IND, IMPD, BLA)
- Technical/scientific leadership and strategic lifecycle thinking
Where You’ll Work
- Hybrid role based in Bridgewater, NJ (remote most of the time; in-person collaboration as needed)
- Occasional travel: ~5%–15%
We’re looking for a Formulation Scientist on the CMC Development team. You’ll lead drug product formulation development activities for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. You will also provide technical leadership and mentorship to junior scientists.
What You'll Do
- Design, develop, and optimize biologics drug product formulations (aqueous and non-aqueous)
- Develop high-concentration formulations for subcutaneous delivery
- Characterize and optimize excipient systems, buffers, and stabilization strategies; evaluate stability, aggregation, viscosity, and degradation pathways
- Conduct forced degradation and stress studies to define formulation design space
- Lead analytical characterization of biologic molecules and formulations (e.g., higher-order structure, aggregation, particle formation, colloidal behavior)
- Investigate degradation pathways, structure–function relationships, and critical quality attributes; develop/qualify/implement analytical methods for formulation screening and optimization
- Provide technical leadership for formulation strategy, candidate selection, and developability assessments
- Support late-stage activities (comparability, stability strategy, lifecycle management)
- Author/review/approve technical reports, protocols, and regulatory documentation (IND/IMPD/BLA)
- Lead/support technology transfer to internal manufacturing sites and CDMOs (formulation/characterization)
Who You Are
- PhD with 2 years’ experience in formulation development, or MS with 6 years’ experience.
You Are Or You Also Have
- Biologics drug product formulation experience (aqueous and/or non-aqueous)
- Advanced analytical techniques (chromatography, spectroscopy, light scattering, calorimetry)
- Strong biologics analytical characterization skills (SEC, DLS, DSC, spectroscopy)
- Knowledge of protein stability, degradation mechanisms, and structure–property relationships
- Experience supporting early- and late-stage development programs
Nice To Have (Not Required)
- Degree in a related field
- Mentoring/leading experience
- Fast-paced, matrixed environment experience
- CDMO/external partner hands-on experience
- Regulatory filing familiarity (IND, IMPD, BLA)
- Technical/scientific leadership and strategic lifecycle thinking
Where You’ll Work
- Hybrid role based in Bridgewater, NJ (remote most of the time; in-person collaboration as needed)
- Occasional travel: ~5%–15%