Associate Director, Formulation Development

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.

What you’ll do

• 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; 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; characterize higher-order structure, aggregation, particle formation, and colloidal behavior
• Investigate degradation pathways, structure–function relationships, and critical quality attributes; 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)

Who you are

• 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 have

• 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

Where you’ll work

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.

Travel requirements

This role requires occasional travel (approximately 5%–15%).

Pay

$155,000.00–$201,500.00 annual

Life at Insmed

• 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