{"id":1684167,"url":"https://alion.io/job/abzena-manufacturing-lead-shift-b","title":"Manufacturing Lead - Shift B","company":{"id":2138905,"name":"Abzena","domain":"abzena.com","url":"https://alion.io/company/abzena","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":75,"open_postings":5,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-12T06:55:09Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85000,"max":100000,"currency":"USD","period":"year","gross":null,"usd_annual":100000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-07-06T13:56:29Z","employer_posted_date":"2026-07-06","last_verified_at":"2026-10-13T01:01:33Z","board_verified":true,"closed_at":null,"days_open":98,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":97},"description":"The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities.\nThe Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.\nExample Plan Shifts/Training Schedule:\n- First 2 weeks: 8 hour shifts, M-F\n- Next 1-2 months: 10 hour shifts, Mon-Thurs\n- After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays\nSchedule is subject to change based on needs.\nResponsibilities\nManufacturing Operations Individual Skills\nProvide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution. \nAdhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. \nPerform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes.\nPerform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills.\nMonitor processes and results and troubleshoot issues as they arise to ensure process success.\nLead and guide associates through process and workflow improvement initiatives.\nLead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. \nSetup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE.\nPerform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.\nEnforce cleanroom standards for cleanliness and order\nDirect floor operations for multiple projects simultaneously. \nMake adjustments as necessary to adhere to production schedules.\nCross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. \nRepresent departmental activities as needed, including project teams and task forces.\nReview GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements.\nDraft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation.\nAdhere to quality standards set by regulations and Abzena policies, procedures, and mission. \nOperate to the highest ethical and moral standards. \nAdjust to a flexible work schedule including weekend work, as needed. \nPerform additional duties as assigned.\nManufacturing Operations Leadership\nLead day-to-day execution of upstream and downstream GMP manufacturing activities. \nCoordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution. \nSupport media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. \nEnsure activities are performed according to approved batch records, SOPs, and production schedules. \nProvide hands-on training and qualification support for manufacturing personnel. \nReview GMP documentation for completeness, accuracy, and compliance. \nSupport deviations, CAPAs, change controls, and quality events. \nTroubleshoot process, equipment, and operational issues. \nChampion EHS compliance and safe work practices. \nPartner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. \nTeam Leadership & Development\nTrain Manufacturing Associates.\nProvide feedback and review of staff during performance evaluations.\nFacilitate onboarding and qualification of new employees.\nPromote a culture of safety, teamwork, accountability, and continuous improvement.\nLead daily shift meetings, production reviews, and operational communications.\nGMP Compliance & Quality\nEnsure strict compliance with cGMP regulations, company procedures, and regulatory requirements.\n Review and verify batch documentation for accuracy and completeness.\nSupport investigations, deviations, CAPAs, change controls, and quality events.\nParticipate in internal audits, client audits, and regulatory inspections.\nEnsure proper documentation practices and data integrity standards are maintained.\nProcess Execution & Technical Support\nProvide technical oversight for upstream and downstream operations.\nSupport process transfers from development to GMP manufacturing.\nAssist in process validation, engineering runs, and GMP campaign readiness activities.\nCollaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency.\nTroubleshoot manufacturing and equipment-related issues.\nSafety & Operational Excellence\nChampion Environmental Health and Safety (EHS) compliance.\nEnsure safe handling of biological materials, chemicals, and manufacturing equipment.\nLead risk assessments and support implementation of corrective actions.\nDrive Lean Manufacturing and continuous improvement initiatives.\nMonitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.\nCross-Functional Collaboration\nPartner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams.\nSupport customer visits and client-facing manufacturing discussions as required.\nEnsure manufacturing readiness through effective planning and material coordination.\nQualifications\nBA/BS degree that included laboratory work in a chemistry, biology, or related field.\nAt least 3 - 4 years of purification experience in a GMP pharmaceutical/biotech environment role.\nDemonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. \nSkilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems.\nSkilled with using single-use technologies\nStrong technical and mechanical aptitude in bioprocessing.\nKnowledge of purification using column chromatography\nExperience leading, training, and coaching peers.\nComputer proficiency\nA proven ability to confidently compute basic arithmetic operations.\nTravel between Abzena sites (local San Diego CA facilities ) as needed. \nPhysical Requirements\nAbility to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.\nFrequently lift and or move objects at least 30 pounds in weight.\nStand/walk during entire length of shift.\nUse arms, hands and fingers to handle, feel or reach.\nAbility to climb, balance, stoop, kneel, crouch, or crawl.\nVisual abilities including near and far sight, color, peripheral vision, depth and ability to 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