Upstream Manufacturing Associate

Job Title: Upstream Manufacturing Associate Position SummaryThe Upstream Manufacturing Associate supports GMP-compliant upstream bioprocessing activities within a CDMO environment. This role is responsible for executing cell culture operations, bioreactor runs, and associated documentation to support clinical and commercial manufacturing programs. The ideal candidate has hands-on upstream manufacturing experience, a strong understanding of GMPs, and the ability to work across multiple client programs in a fast-paced, regulated environment.Key ResponsibilitiesUpstream Manufacturing OperationsExecute GMP upstream manufacturing activities including:Mammalian cell culture expansion and maintenanceSeed train operationsOperation of single-use and/or stainless-steel bioreactorsMedia and buffer preparationPerform inoculation, feeding, sampling, monitoring, and harvest operationsOperate process equipment (bioreactors, incubators, centrifuges, mixers, filtration systems)Perform in-process sampling and basic testing (e.g., cell counts, viability, metabolite analysis)Documentation & ComplianceAccurately complete GMP documentation including batch records, logbooks, and electronic systemsFollow standard operating procedures (SOPs), batch production records (BPRs), and work instructionsSupport deviation investigations, CAPAs, and change controls as neededParticipate in internal and client audits and regulatory inspectionsProcess Support & Continuous ImprovementIdentify and escalate process deviations or equipment issuesSupport technology transfer, process characterization, and scale-up activitiesAssist with troubleshooting manufacturing issues and implementing process improvementsContribute to 5S, lean manufacturing, and continuous improvement initiativesTraining & CollaborationTrain and mentor junior manufacturing associates as assignedCollaborate cross-functionally with Quality, MSAT, Facilities, and Supply Chain teamsSupport multi-client manufacturing schedules typical of a CDMO environmentRequired QualificationsBachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Biology, or a related scientific fieldMinimum of 3 years of hands-on upstream GMP manufacturing experience in a biotech, pharmaceutical, or CDMO environmentExperience with mammalian cell culture and bioreactor operationsWorking knowledge of cGMP regulations and documentation practicesAbility to work in cleanroom environments and follow aseptic techniquesStrong attention to detail and ability to follow complex proceduresPreferred QualificationsExperience in a CDMO or multi-product manufacturing environmentExperience with single-use bioreactor systems (e.g., Sartorius, Cytiva, Thermo Fisher)Familiarity with MES, electronic batch records, and data integrity requirementsExperience supporting clinical and/or commercial manufacturing campaignsPhysical & Schedule RequirementsAbility to work shifts, weekends, or extended hours as required by manufacturing schedulesAbility to lift up to [X] lbs and perform repetitive tasks while wearing appropriate PPEAbility to work in controlled cleanroom environments for extended periodsCore CompetenciesGMP compliance and quality mindsetTeam-oriented and collaborative approachStrong communication and documentation skillsAdaptability in a fast-paced, client-driven environment

Salary : $22 - $27