Associate Director, Formulation Development

About the role

We're seeking a Formulation Scientist on the CMC Development team to help expand possibilities for patients with serious diseases. You'll lead drug product formulation development for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. You'll also provide technical leadership and mentorship to junior scientists.

Responsibilities

• Design, develop, and optimize biologics drug product formulations, including aqueous and non-aqueous systems
• Develop high-concentration formulations to enable subcutaneous delivery and improve patient convenience
• Characterize and optimize excipient systems, buffer conditions, and stabilization strategies, and evaluate physicochemical stability, aggregation, viscosity, and degradation pathways
• Conduct forced degradation and stress studies to understand product stability and define formulation design space
• Conduct comprehensive analytical characterization of biologic molecules and formulations to inform formulation development and 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
• 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)

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

Qualifications

• Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or related discipline
• Prior experience mentoring or leading junior scientists or technical staff
• Hands-on experience with CDMOs and external development partners
• Familiarity with regulatory expectations and filings (IND, IMPD, BLA)
• Strategic thinking across product lifecycle
• Quality mindset and regulatory awareness

Skills

• Formulation development
• Biologics drug product formulation development
• High-concentration formulations
• Subcutaneous delivery
• Excipient systems
• Buffer conditions
• Stabilization strategies
• Physicochemical stability
• Aggregation
• Viscosity
• Degradation pathways
• Structure-function relationships
• Critical quality attributes
• Analytical methods
• Technology transfer

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and various employee benefits including paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules. We also provide a 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.

Pay

$155,000.00 - $201,500.00 Annual

Schedule

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

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

Human Resources Department

The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Equal Opportunity Employer

Insmed is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.