Director, Process Chemistry

Insmed Incorporated•NJ Corporate Headquarters, NJ

9d•$177,000 - $242,000•Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? 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.

Requirements

PhD along with 5+ 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.

Nice To Haves

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.

Responsibilities

Manage API/Intermediate/RSM manufacturing at Insmed’s CMOs.
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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
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
Meaningful opportunities to connect, volunteer, and give back