Director, Upstream Process Development and Manufacturing

Insmed Inc. • Bridgewater, NJ • 1h ago

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, Upstream PD and Manufacturing 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.What You'll Do: In this role, you'll have the opportunity to partner closely with drug substance development, analytical development, external manufacturing, supply chain, and broader CMC teams to guide both technical execution and strategic decision making. You'll also: 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 commercializationWho You Are: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.You are or you also have: 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 a

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