{"id":4296458,"url":"https://alion.io/job/abzena-lead-manufacturing-operations","title":"Lead, Manufacturing Operations","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":"A","score":86,"open_postings":9,"ghost_share":0,"stale_share":0.556,"repost_share":0,"time_to_fill_p50_days":36,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Operations","role_family":"Operations","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":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Bioreactors","optional":false},{"name":"CAPA","optional":false},{"name":"Cell Culture","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-13T22:42:46Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-14T01:29:08Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"The Lead, Manufacturing Operations (Shift B) 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.\nResponsibilities\nManufacturing Operations Individual Skills\nAdhere to appropriate gowning procedures required for working in ISO 5 - ISO 8 cleanrooms. \nPerform aseptic operations in a bio-safety cabinet.\nSetup, operate and maintain upstream bioprocessing equipment including single-use bioreactors up to 2000 L, large scale filtration skids, and automated filling machines and analytical instruments for cell culture such as Nova Bioprofile and Vi-Cell systems.\nPerform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, cell culture harvests, and master cell bank and bulk drug substance fills.\nMonitor processes and results and troubleshoot issues as they arise to ensure process success.\nSetup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, large scale filtration skids, and analytical instruments such as SoloVPE.\nPerform downstream production activities including depth filtration, purification through various modes of chromatography, viral inactivation, viral filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.\nEnforce cleanroom standards for cleanliness and order.\nCross-train on various tasks including formulation of buffers, facility cleanings, and other operations to support the overall success of the Manufacturing organization. \nRepresent departmental activities as needed, including project teams and task forces.\nReview executed GMP records on a daily basis for completeness, accuracy, and compliance.\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 and support 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. \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. \nTroubleshoot process, equipment, and operational issues. \nChampion EHS compliance and safe work practices. \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.\nLead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. \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\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.","description_format":"text","description_chars":5979,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Process Manufacturing","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-11-14T01:29:08Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":36,"reasons":["conf:2","win:early"],"computed_at":"2026-11-14T03:41:26Z"},"pay":null,"html_url":"https://alion.io/job/abzena-lead-manufacturing-operations","json_url":"https://alion.io/job/abzena-lead-manufacturing-operations.json","meta":{"generated_at":"2026-11-14T03:41:26Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":5647,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2138905},"rest":"https://alion.io/mcp/rest/get_company?id=2138905"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabzena-lead-manufacturing-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fabzena-lead-manufacturing-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fabzena-lead-manufacturing-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/abzena-lead-manufacturing-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabzena-lead-manufacturing-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4296458}},{"tool":"search_jobs","arguments":{"company":"abzena.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4296458},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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