Senior Scientist Formulation and Process Development

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:

• 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

Who You Are:

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.

You are or you also have:

• 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 have (but not required):

• Experience with inhalation formulations is a plus

Where You’ll Work

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

This role requires occasional domestic travel (approximately 10%–15%).

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Pay Range:

$124,000.00-161,000.00 Annual

Life at Insmed
 

At 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 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. 

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@insmed.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.