Senior Scientist Formulation and Process Development

Insmed Incorporated

8d • Onsite

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 Senior Scientist, Formulation and Process Development on the Pharmaceutical and Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Formulation Development, you’ll lead the design, optimization, and scale-up of oral drug products supporting clinical and commercial programs. This role combines hands-on formulation development with oversight of CDMO activities and GMP manufacturing campaigns. The individual will author high-quality technical reports and CMC regulatory documentation (IND/NDA) aligned with FDA and ICH expectations. The position requires strong scientific rigor, cross-functional collaboration, and the ability to translate experimental data into clear development strategy. What You'll Do: In this role, you’ll have the opportunity to be instrumental in advancing our oral drug product pipeline through the development, optimization, and scale-up of robust and patient-centric formulations. You’ll also:

Requirements

• You have a MS in Pharmaceutical Sciences or related discipline along with 5+ years of relevant experience in formulation and process development, or BS in Pharmaceutical Sciences in related discipline with 7+ years of relevant experience.
• Proven experience in writing technical and regulatory documents, including CMC sections of INDs/NDAs, development reports, and technology transfer documents
• Strong knowledge of FDA and EMA regulatory guidelines, ICH quality standards, and the end-to-end drug development process
• Hands-on experience with oral formulation development, including pre-formulation studies, process development, and scale-up
• Excellent skills in technical writing, data analysis, and scientific communication—both verbal and written
• Strong ability to work independently while also contributing effectively in cross-functional teams
• Demonstrated scientific rigor, attention to detail, integrity, and organizational discipline

Nice To Haves

• Experience with inhalation formulations is a plus

Responsibilities

• Contribute through a combination of hands-on laboratory work, oversight of activities at CROs, and authorship of high-quality technical and regulatory documentation, including formulation development reports and CMC sections of IND and NDA submissions
• Bring a solid foundation in pharmaceutical sciences, strong technical writing and data analysis skills, and the ability to clearly communicate scientific results and strategy to both internal stakeholders and regulatory agencies
• Design and develop solid oral and liquid dosage forms to support early- and late-stage development programs, including preclinical, clinical, and commercial readiness
• Interface with external manufacturing partners (CDMOs) to support formulation and process development, batch record preparation, and GMP manufacturing campaigns
• Author detailed and scientifically rigorous technical documents including Formulation development reports, Manufacturing process descriptions, Justification of critical formulation parameters and technology transfer and process validation documents
• Serve as primary or contributing author for CMC regulatory documentation, including INDs, NDAs, IMPDs, and briefing packages, ensuring alignment with regulatory expectations and internal quality standards
• Analyze, interpret, and summarize experimental data; compile and present results clearly in internal meetings and cross-functional discussions to support decision-making
• Collaborate closely with cross-functional teams including Process Chemistry, Regulatory Affairs, and Analytical Development to align formulation strategy with overall CMC plans
• Operate and troubleshoot formulation lab equipment, and maintain high standards of laboratory documentation and compliance

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level