Scientist, Analytical Development, Small Molecule

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 Scientist, Analytical Development, Small Molecule on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Analytical Development, you’ll support analytical method development and contribute to the testing of small molecule candidates. While experience with inhalation products is a plus, the core responsibilities will include maintaining compliance with regulatory requirements, ensuring data integrity, and collaborating with cross-functional teams to meet project goals. A deep understanding of GMP, quality control processes, and the pharmaceutical development lifecycle is essential for this position.What You'll Do: In this role, you’ll have the opportunity to take the responsibility for small molecule products analytical routine testing (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization. You’ll also:Ensure all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.Contribute to regulatory filings (IND, NDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.Who You Are:You have a Bachelor’s degree along with five years of experience in Chemistry. You are or you also have:Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms. Experience with inhalation and combination products is preferred.Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).Ability to conduct risk assessments and develop analytical methods for the detection and control of nitrosamine impurities, ensuring compliance with regulatory guidelines.Strong commitment to laboratory work with meticulous attention to detail.Advanced proficiency in Microsoft Office tools.Excited to contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development.Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.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 RequirementsMinimal travel expected#LI-BA#LI-ONSITEPay Range:$127,000.00-165,500.00 AnnualLife 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 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. 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.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 View email address on click.appcast.io 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.SummaryLocation: Research Development Lab - New JerseyType: Full time