Jobs at Insmed Incorporated

We’re looking for a Senior Manager, Process Chemistry on the API Development team to help 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.

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 projects

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)