Director, Chemistry, Manufacturing & Controls - CMC

Insmed Incorporated

1d • Onsite

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, CMC on the Process Development and Engineering team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Pharmaceutical Development, you’ll drive the design, optimization, and scale up of upstream processes for therapeutic biologics. This role is central to advancing our innovative biologics portfolio from early development through commercial readiness. You will oversee upstream process development for modalities including monoclonal antibodies, microbial proteins and fusion proteins. You’ll also oversee CDMO/CMO partners and manage the lifecycle of upstream process development, specializing in cell line characterization, media and feed strategy optimization, upstream process scaling, and the process validation to support clinical and commercial progression.

Requirements

• You have a PhD along with 11 years of experience in drug substance development and manufacturing, or a BS/MS with 14 years of relevant experience.
• Proven leadership in upstream process development for recombinant proteins, including antibodies, ADCs, and fusion proteins
• Deep expertise in mammalian cell culture technologies
• Demonstrated success scaling processes to pilot and commercial scale and transferring processes to GMP facilities
• Hands‑on experience with bioreactor platforms (Ambr®, benchtop, pilot, and commercial systems)
• Strong track record of delivering programs with CDMOs
• Experience advancing drug substance from IND through late‑stage development and commercialization
• Expertise in process characterization, control strategy development, and PPQ aligned with QbD principles
• Extensive knowledge of cGMPs and regulatory expectations for biologics, with the ability to influence internal decision‑making
• Strong analytical, data interpretation, and scientific communication skills, including regulatory documentation experience
• Demonstrated leadership managing technical teams and driving cross‑functional collaboration

Nice To Haves

• Degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences
• Regarding mammalian cell culture technologies, CHO preferred
• Experience with continuous or perfusion‑based bioprocessing

Responsibilities

• Lead the upstream process development and manufacturing strategy for biologics (mAbs, fusion proteins, or similar). This includes cell line evaluation, media/feed strategy optimization, bioreactor operations, and scale-up
• Serve as the Insmed’s thought leader for biologics manufacturing platforms, innovation, and process robustness
• Identify, evaluate, and implement innovative technologies—such as perfusion systems, single‑use bioreactors, and process intensification—to enhance yield, robustness, and efficiency
• Partner with stakeholders across R&D, Regulatory, Commercial Manufacturing and Quality to ensure alignment from development to commercial readiness
• Manage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelines
• Lead or support cell line development activities, including clone selection, evaluation, and characterization
• Oversee the generation, characterization, and qualification of Master Cell Banks (MCB) and Working Cell Banks (WCB)
• Develop and manage program timelines, resource planning, and budgets for upstream initiatives
• Manage deviations and OOT/OOS investigations at CDMOs in collaboration with Quality, External Manufacturing, and Regulatory
• Establish control strategies, validation approaches, and process characterization studies aligned with Quality by Design (QbD) principles
• Author and review regulatory submissions including IND/IMPD filings, briefing documents, and BLAs
• Serve as a subject matter expert during regulatory interactions, audits, and inspections
• Potential future responsibility to build and lead a team of scientists and engineers supporting upstream development from early research through commercialization

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), 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree