Senior 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 Senior Scientist, Analytical Development on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Analytical Development, you’ll lead analytical development efforts for small-molecule drug substances and drug products. This role will support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success.What You'll Do: In this role, you’ll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products. You’ll also:Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications.Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.Lead or contribute to cross-functional project teams, manage analytical development timelines, and communicate progress to stakeholders.Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners.Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements.Provide technical troubleshooting, data interpretation, and review of analytical data, including method validation documents, Certificates of Analysis (CoAs), and stability reports.Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for drug substances and drug products.Contribute to CMC operations, including execution, process improvements, and development of operational capabilities.Collaborate with cross-functional teams across the organization to establish and enhance technical and business practices.Perform additional responsibilities as assigned to support evolving departmental needs.Who You Are:You have a bachelor’s degree in chemistry, Biochemistry, or related discipline with 6+ years of experience, or master’s degree with 4+ years of experience.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). Strong commitment to laboratory work with meticulous attention to detail. Advanced proficiency in Microsoft Office tools. 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 WorkThis 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