Scientist, Analytical Development, Small Molecule
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 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.
Requirements
- Bachelor’s degree along with five years of experience in Chemistry.
- Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms.
- 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.
Nice To Haves
- Experience with inhalation and combination products is preferred.
Responsibilities
- 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.
- 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.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- 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
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Senior
