About the Role:
We're looking for a 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, 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:

• 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

Who You Are:

You have a PhD along with 5+ years of experience managing development and execution of API manufacturing processes

You are or you also have:

• 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

Nice to have (but not required):

• PhD in Organic Chemistry (Organic Synthesis) or Chemical Engineering (Crystallization/Solid State expertise)

• 10+ years of experience managing development and execution of API manufacturing processes of products marketed in the US, EU, JP for entire development to launch lifecycle

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:
$177,000.00-242,000.00 Annual

Life at Insmed

At 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.