Associate Director, Formulation Development
About The Position
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. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: 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.
Requirements
- PhD with 2 years of experience or MS with 6 years of experience in formulation development.
- 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 Haves
- 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
Responsibilities
- 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 developability 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)
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
