Senior Manager- Manufacturing Operations (Biologics & Gene Therapy)

JOB DESCRIPTION\n\nJob title : Senior Manager– Manufacturing Operations (Biologics &Gene Therapy)\nReports to : VP - Operations\n\nJob purpose\nWe are seeking an experienced and highly motivated Senior Manager – Manufacturing Operations to support development activities for gene therapy and biologics programs. The role will oversee CMC manufacturing operations across process development, technology transfer, GMP manufacturing.\nThe ideal candidate will bring strong expertise in biologics and advanced therapy manufacturing, including viral vectors, cell culture operations, downstream processing, and GMP compliance. This individual will collaborate closely with Quality, Regulatory, Process Development, MSAT, and external CDMO partners to ensure timely and compliant execution of manufacturing strategies.\n\nDuties and responsibilities\nManage upstream and downstream manufacturing operations including viral vector production, biologics processing, purification, formulation, and fill-finish coordination.\nOversee technology transfer activities between development, manufacturing sites, and CDMOs.\nEnsure GMP-compliant manufacturing execution and adherence to regulatory expectations including FDA, EMA, and ICH guidelines.\nCoordinate batch manufacturing schedules, material readiness, production documentation, and deviation management.\nCollaborate with QA, QC, Regulatory Affairs, Supply Chain, and Process\nReview and approve batch records, SOPs, protocols, change controls, CAPAs, and technical reports.\nDrive process optimization, manufacturing efficiency improvements, and operational excellence initiatives.\nSupport regulatory submissions including IND, BLA, and CMC documentation preparation.\nMonitor manufacturing KPIs, production timelines, and risk mitigation strategies.\nManage external manufacturing partners and ensure deliverables meet quality and timeline expectations.\nManage manufacturing CMC activities for gene therapy and biologics programs from clinical through commercial stages.\nMentor and guide junior manufacturing and technical operations staff.\n\nQualifications and Experience\nMaster’s, or PhD in Biotechnology, Biochemical Engineering, Life Sciences, or related discipline.\n12 to 15 years of experience in biologics, cell & gene therapy, or biopharmaceutical manufacturing process.\nStrong understanding of CMC development and GMP manufacturing requirements.\nHands-on experience with viral vectors (AAV, Adenovirus), mammalian cell culture, purification systems, and aseptic processing preferred.\nExperience managing CDMOs and technology transfer activities.\nKnowledge of regulatory requirements for biologics and gene therapy products.\nFamiliarity with single-use systems, cleanroom operations, and manufacturing scale-up.\nStrong leadership, project management, and cross-functional collaboration skills.\nExcellent communication and technical documentation abilities.\n\nPreferred Skills\nExperience supporting late-stage clinical development programs.\nExposure to digital manufacturing systems, MES, or electronic batch records.\nLean manufacturing or operational excellence experience.\nPMP or Six Sigma certification is a plus.\n\nWorking conditions\nThis position operates in an office setting,in person.\nJob may additionally require incumbent to be available outside of these hours to handle priority business needs.\n\nDirect Reports\nN/A