Unknown Company

Associate Director, Formulation Development

bridgewater, nj • Posted 3 days ago
Remote Full Time General

Formulation ScientistAt 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 systemsDevelop high-concentration formulations to enable subcutaneous delivery and improved patient convenienceCharacterize and optimize excipient systems, buffer conditions, and stabilization strategies as well as evaluate physicochemical stability, aggregation, viscosity, and degradation pathwaysConduct forced degradation and stress studies to understand product stability and define formulation design spaceLead 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 optimizationProvide technical leadership for formulation strategy, candidate selection, and developability assessmentsSupport late-stage activities including comparability, stability strategy, and lifecycle managementAuthor, 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 interactionsStrong expertise in analytical characterization techniques for biologics (e.g., SEC, DLS, DSC, spectroscopy methods)Strong understanding of protein stability, degradation mechanisms, and structure–property relationshipsExperience supporting early- and late-stage development programsNice to have (but not required):Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or related disciplinePrior experience mentoring or leading junior scientists or technical staffAbility to operate effectively in a fast-paced, matrixed environmentHands-on experience with CDMOs and external development partnersFamiliarity with regulatory expectations and filings (IND, IMPD, BLA)Scientific and technical leadership in drug product formulation and characterizationStrategic thinking across product lifecycleQuality mindset and regulatory awarenessThis 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: $155, ,500.00 AnnualAt 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 grow, and how you show up for patients, your team, and yourself.Highlights of our U.S. offerings include: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 collaboration401(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 insuranceCompany Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan.

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