{"id":3280495,"url":"https://alion.io/job/genezen-manager-manufacturing-reliability-human-performance","title":"Manager, Manufacturing Reliability & Human Performance","company":{"id":719970,"name":"Genezen","domain":"genezen.com","url":"https://alion.io/company/genezen","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":94,"open_postings":4,"ghost_share":0,"stale_share":0.25,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Lexington, United States","Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":130000,"max":165000,"currency":"USD","period":"year","gross":null,"usd_annual":165000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-26T11:17:41Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-28T18:55:43Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. \nWORKING AT GENEZEN\nMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.\nJOB SUMMARY\nLead hands-on, cross-site improvement efforts to reduce recurring GMP deviations, prevent avoidable manufacturing failures, and improve batch success rates in gene therapy manufacturing. \nApply human performance principles, structured problem solving, standard work, and error-proofing to strengthen process reliability. Partner closely with Manufacturing, Quality, MSAT, and Engineering to implement sustainable improvements while maintaining patient safety, data integrity, and GMP compliance. \nESSENTIAL JOB FUNCTIONS \nChampion a continuous improvement mindset across the organization, fostering accountability, innovation, and operational excellence.\nLead a prioritized, multi-site portfolio of improvement projects focused on repeat deviations, preventable batch losses, and manufacturing execution reliability. \nAnalyze deviation, batch outcome, and process performance data to identifyrecurring failure mechanisms, risk concentrations, and opportunities for prevention.\nFacilitatecross-functional root-cause and human-factorsanalyses, distinguishing process design weaknesses from individual actions; supportQuality-led GMP investigations and CAPA without assuming Quality ownership.\nDesign, pilot, and implement practical countermeasures including error-proofing, visual controls, simplified work steps, verification methods, and robust shift handoffs.\nPartner with Manufacturing and MSAT to investigate controllable causes of unsuccessful batches, including execution, process variability, material handling, equipment interfaces, and process interruptions.\nImprove critical standard work and execution practices with process owners; ensure changes to GMP procedures and records follow approved change control.\nPersonally lead focused Kaizen and DMAIC-based improvement activities, from problem definition and baseline through implementation and effectiveness verification.\nEstablishconsistent, meaningful measures for repeat deviation rates, targeted failure modes, batch success, and sustained countermeasure effectiveness.\nConduct shop-floor observation and process confirmation with site leaders to identifysystem vulnerabilities and reinforce reliable execution.\nCoach supervisors and frontline teams in problem visibility, human performance, structured problem solving, and practical prevention techniques.\nReplicate proven improvements across sites where processes and regulatory requirements are comparable.\nCommunicate progress, barriers, and verified benefits to site leadership and Continuous Improvement; escalate risks promptly.\nMaintainstrong collaboration with Quality, Operations, MSAT, Engineering, Supply Chain, and Training, respecting functional accountability for batch disposition, investigations, and technical process ownership. \nSPECIAL JOB REQUIREMENTS\nRegular presence in GMP manufacturing environments and travel between company sites as business needs require.\nFlexibility in schedule to support critical manufacturing and improvement activities.\nCriminal background check required.\nOther duties as assigned. \nKNOWLEDGE, SKILLS AND EXPERIENCE\n\nAt least 7 years of relevant experience in GMP pharmaceutical, biologics, or advanced therapy manufacturing, quality, or operational excellence.\nDemonstratedhands-on delivery of deviation reduction, process reliability, or manufacturing performance improvements.\nExperience leading cross-functional projects without direct line authority; gene therapy or cell therapy experience preferred.\nWorking knowledge of cGMP, deviation investigation, CAPA, change control, and data integrity requirements.\nPractical expertisein human factors, error-proofing, standard work, process observation, and recurrence prevention. \nStrong structured problem-solving capability (e.g., DMAIC, 5 Why, cause-and-effect, risk assessment, and Kaizen).\nAbility to analyze batch and deviation trends, define defensible baselines, and verify sustained improvement.\nManufacturing-floor credibility and ability to turn analysis into implemented countermeasures. \nStrong collaboration and influencing skills across Operations, Quality, MSAT, and Engineering. \nClear written and verbal communication, sound judgment, and commitment to patient safety and compliance. \nAbility to prioritize work across multiple sites and balance near-term delivery with lasting process control.\n\nEssential\n\nCOMPENSATION RANGE:\nThe anticipated annual salary range for the Manager is $130,000 - $165,000. Salary determined based on relevant experience, skills and education.\nPHYSICAL DEMANDS \nWhile performing the duties of this job, the employee is required to meet the following physical demands:\nWork Environment:\nRegularly sit for long periods of time\nMovement:\nFrequently required to stand; sit.\nOccasionally required to walk; climb or balance; and stoop/crouch.\nVision:\nFrequently utilize close vision and the ability to adjust focus\nCommunication\nFrequently required to communicate by talking, hearing, using telephone and e-mail\nGENEZEN'S CURESVALUE-BASED COMPETENCIES\nCommitted to Science\nWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.\nUrgency in action for the patients\nWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.\nResilience & Grit in operations\nWe are committed to overcoming challenges, learning from failures, and persistently striving for success. \nExecute with Excellence & Integrity\nWe are dedicated to delivering quality results and upholding ethical principals.\nSolutions driven for our partners\nWe are committed to being a proactive, collaborative, creative and open-minded partner.\nGENEZEN'S BENEFITS\nPaid vacation days, amount based on tenure\nPaid sick time\n10 observed holidays + 2 floating holiday + 1 volunteer day\n401(k) plan with company match up to 6% of salary\nShare Appreciation Rights\nChoice of several healthcare plans\nFSA and HSA programs\nDental & vision care\nEmployer-paid basic term life/personal accident insurance\nVoluntary disability, universal life/personal accident insurance\nAccidental Death & Dismemberment (AD&D) Insurance\nADDITIONAL DETAILS\nNothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nThis position requires a criminal background check.\nGenezen is an Equal Opportunity Employer.\nGenezen participates in EVerify.\nGenezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.\nGenezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. \nFishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.\nLexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.","description_format":"text","description_chars":8473,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-26T16:15:47Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":46,"reasons":["conf:0","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":165000,"is_top_pay":true},"html_url":"https://alion.io/job/genezen-manager-manufacturing-reliability-human-performance","json_url":"https://alion.io/job/genezen-manager-manufacturing-reliability-human-performance.json","meta":{"generated_at":"2026-10-28T21:06:57Z","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":29092,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":719970},"rest":"https://alion.io/mcp/rest/get_company?id=719970"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenezen-manager-manufacturing-reliability-human-performance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fgenezen-manager-manufacturing-reliability-human-performance"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fgenezen-manager-manufacturing-reliability-human-performance"},{"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/genezen-manager-manufacturing-reliability-human-performance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenezen-manager-manufacturing-reliability-human-performance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3280495}},{"tool":"search_jobs","arguments":{"company":"genezen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3280495},"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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