Director, Upstream Process Development and Manufacturing

Director, Upstream PD and ManufacturingAt 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-upServe as the Insmed's thought leader for biologics manufacturing platforms, innovation, and process robustnessIdentify, evaluate, and implement innovative technologiessuch as perfusion systems, single?use bioreactors, and process intensificationto enhance yield, robustness, and efficiencyPartner with stakeholders across R&D, Regulatory, Commercial Manufacturing and Quality to ensure alignment from development to commercial readinessManage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelinesLead or support cell line development activities, including clone selection, evaluation, and characterizationOversee 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 initiativesManage deviations and OOT/OOS investigations at CDMOs in collaboration with Quality, External Manufacturing, and RegulatoryEstablish control strategies, validation approaches, and process characterization studies aligned with Quality by Design (QbD) principlesAuthor and review regulatory submissions including IND/IMPD filings, briefing documents, and BLAsServe as a subject matter expert during regulatory interactions, audits, and inspectionsPotential 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 proteinsDeep expertise in mammalian cell culture technologiesDemonstrated success scaling processes to pilot and commercial scale and transferring processes to GMP facilitiesHands?on experience with bioreactor platforms (Ambr, benchtop, pilot, and commercial systems)Strong track record of delivering programs with CDMOsExperience advancing drug substance from IND through late?stage development and commercializationExpertise in process characterization, control strategy development, and PPQ aligned with QbD principlesExtensive knowledge of cGMPs and regulatory expectations for biologics, with the ability to influence internal decision?makingStrong analytical, data interpretation, and scientific communication skills, including regulatory documentation experienceDemonstrated leadership managing technical teams and driving cross?functional collaborationNice to have (but not required):Degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical SciencesRegarding mammalian cell culture technologies, CHO preferredExperience with continuous or perfusion?based bioprocessingWhere You'll WorkThis is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.Travel RequirementsThis role requires occasional domestic and international travel (approximately 10-20%).Pay Range:$177,000.00-242,000.00 Annual