[Hiring] Associate Director, Process Chemistry @Insmed Incorporated

Role Description

We’re looking for an Associate Director, 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:

• Synthesis route and early-stage process identification
• Tech transfer
• Process optimization
• Clinical/commercial manufacturing
• Process characterization and validation
• 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:

• Act as the Technical Operations collaborator with the Insmed research team for lead optimization and early development programs
• Drive the dynamic cross‑functional interaction between lead optimization research and early CMC development via a discovery process chemistry (DPC) philosophy
• 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, management of schedule/raw material consumption/budgets, and management of any process improvement related projects

Qualifications

• PhD along with 2+ years of experience managing development and execution of API manufacturing processes
• OR Master’s along with 6+ years of experience managing development and execution of API manufacturing processes
• 5+ years of experience leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment
• Experience managing 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
• Experience with providing technical authoring 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

Requirements

• Nice to have (but not required): PhD in Organic Chemistry (synthesis) or Chemical Engineering (crystallization)
• 10+ years of experience managing development and execution of API manufacturing processes of products marketed in the US, EU, JP

Benefits

• 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)
• 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