Associate Director, Formulation Development
Listed on 2026-07-21
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Science
Pharmaceutical Science/ Research
Formulation Scientist
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress.
We're looking for a Formulation Scientist on the CMC Development team to help us expand what's possible for patients with serious diseases. You'll lead drug product formulation development activities for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. Additionally, you will provide technical leadership and mentorship to junior scientists, fostering a collaborative and high-performing team environment.
In this role, you'll have the opportunity to contribute across early- and late-stage development, supporting formulation design through deep analytical characterization and molecular understanding. You'll also:
- Design, develop, and optimize biologics drug product formulations, including aqueous and non-aqueous systems
- Develop high-concentration formulations to enable subcutaneous delivery and improved patient convenience
- Characterize and optimize excipient systems, buffer conditions, and stabilization strategies as well as evaluate physicochemical stability, aggregation, viscosity, and degradation pathways
- Conduct forced degradation and stress studies to understand product stability and define formulation design space
- Lead comprehensive analytical characterization of biologic molecules and formulations to inform formulation development as well as characterize higher-order structure, aggregation, particle formation, and colloidal behavior.
- Investigate degradation pathways, structure–function relationships, and critical quality attributes and develop, qualify, and implement analytical methods to support formulation screening and optimization
- Provide technical leadership for formulation strategy, candidate selection, and develop ability assessments
- Support late-stage activities including comparability, stability strategy, and lifecycle management
- Author, review, and approve technical reports, protocols, and regulatory documentation (IND/IMPD/BLA)
- Lead and support technology transfer activities to internal manufacturing sites and CDMOs (from a formulation and characterization perspective)
You have a PhD with 2 years of experience or MS with 6 years of experience in formulation development.
You are or you also have:
- Demonstrated experience in biologics drug product formulation development (aqueous and/or non-aqueous systems)
- Advanced analytical techniques (e.g., chromatography, spectroscopy, light scattering, calorimetry) to assess structure, stability, and interactions
- Strong expertise in analytical characterization techniques for biologics (e.g., SEC, DLS, DSC, spectroscopy methods)
- Strong understanding of protein stability, degradation mechanisms, and structure–property relationships
- Experience supporting early- and late-stage development programs
Nice to have (but not required):
- Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or related discipline
- Prior experience mentoring or leading junior scientists or technical staff
- Ability to operate effectively in a fast-paced, matrixed environment
- Hands-on experience with CDMOs and external development partners
- Familiarity with regulatory expectations and filings (IND, IMPD, BLA)
- Scientific and technical leadership in drug product formulation and characterization
- Strategic thinking across product lifecycle
- Quality mindset and regulatory awareness
This is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.
This role requires occasional travel (approximately 5%–15%)
Pay Range: $- Annual
At Insmed, you'll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you…
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