Senior Manager, Process Chemistry
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 Manager, Process Chemistry on the API Development team to help us expand what’s possible for patients with serious diseases. You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.
Requirements
- PhD OR Master’s along with 3+ years of experience managing development and execution of API manufacturing processes
- 2+ years of experience contributing to teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment
- Experience collaborating with CMO operations
- Experience in NCE including total synthesis, physical organic chemistry
- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals
- Working knowledge of CMC drug substance sections of regulatory filings and dossiers
- Sound awareness of Regulatory, Quality Assurance, and cGMP requirements
- High energy, innovative “can do” attitude
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment
- Strong verbal and written communication skills are essential
Nice To Haves
- Master’s or PhD in Organic Chemistry (synthesis) or Chemical Engineering (crystallization)
- 4+ years of experience in development and execution of API manufacturing processes (preferably of products marketed in the US, EU, JP)
Responsibilities
- Manage oversight of tech transfer, scale-up, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process
- Provide technical support as Insmed’s internal SME, technical review of quality documentation, and management of any process improvement related proj
- Periodic technical support to commercial product portfolio
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
