Senior Manager, Process Chemistry
Insmed Incorporated
Summary
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.
Job description
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
- 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 projects
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
- 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%).
Requirements
- PhD OR Master's 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
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment
- Strong verbal and written communication skills are essential
Benefits
- Medical, Dental & Vision
- Mental Health Support
- Wellbeing Reimbursement
- Employee Assistance Program
- Paid Time Off
- Fertility & Family-Forming Benefits
- Caregiver Support
- Flexible Work Schedules
- 401(k) Matching
- Annual Equity Awards
- Employee Stock Purchase Plan
- Life & Disability Insurance
- LinkedIn Learning
- Skill Building Workshops
- Leadership Programs
- Mentorship Connections
Company overview
Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.