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.
What You'll Do: In this role, you'll have the opportunity to manage API/Intermediate/RSM manufacturing at Insmed's CMOs. You'll also:
- 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
Who You Are:You have a PhD
OR
You have a Master's along with 3+ years of experience managing development and execution of API manufacturing processes
You are or you also have:
- 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
- Periodic technical support to commercial product portfolio
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment
- Strong verbal and written communication skills are essential
Nice to have (but not required):- 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)
Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements This role requires occasional domestic/international travel (approximately 10%)
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Pay Range:$127,000.00-165,500.00 Annual
Life at InsmedAt 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.Applications are accepted for 5 calendar days from the date posted or until the position is filled.
