{"id":3029418,"url":"https://alion.io/job/genezen-managersenior-manager-quality-control-microbiology","title":"Manager/Senior Manager, Quality Control - Microbiology","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":"B","score":83,"open_postings":3,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-11-05T05:54:30Z"}},"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"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":95000,"max_usd":179000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-21T19:25:15Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-11-05T07:06:08Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"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.\nPURPOSE\nResponsible management of the Microbiology laboratory and personnel and execution of the site Environmental and Personnel Monitoring program. This individual is expected to have strong, hands-on, and technical experience of microbiological assays (Endotoxin, Bioburden, TOC) and Environmental Monitoring.\nThe Microbiology Manager ensures strict adherence to all cGMP/GMP policies and standard operating procedures, provides microbiology technical expertise, and communications effectively with other departments.\nThe Manager will also have a proven track record with Continuous Improvement and be a champion for the change within the Microbiology team and the QC organization as a whole.\nESSENTIAL JOB FUNCTIONS / DUTIES\nMaintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOP’s, guidelines and regulations.\nCoordinate day-to-day management of QC Microbiology operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication cross-functionally.\nManage and develop the performance of direct reports by setting clear goals, providing performance feedback, supporting career development and recognizing and rewarding exceptional performance.\nOversee testing in-process samples, drug substance and drug product release/stability and complaint samples.\nOversee performance of environmental and utility monitoring according to SOP’s, sample test requests, and per approved protocols and investigations.\nMaintain data integrity to the highest industry standards,\nOversee timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies.\nManage outsourced testing activities as necessary and ensure results are reported in a timely and compliant fashion.\nDevelop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management, data archiving, and validation and calibration of QC equipment.\nEngage with Continuous Improvement projects cross-functionally that support site improvements and cost efficiency.\nSupport and participate in internal and external inspections and audits including regulatory inspections.\nCollaborate with QC Tech Services for method validation, specification generation, stability studies and support life cycle management of methods, Ref. Std. & Critical reagents.\nSupport new equipment validation and implementation.\nProvide QC data internally and internally and actively support and participate in cross functional teams (CMC, Quality Management, Management Review Meetings, SRB etc.).\nEnsure timely issue escalation to Quality senior management and cross-functional support teams.\nSPECIAL JOB REQUIREMENTS\nAdaptability required as work schedule may change based on business needs\nCriminal background check and drug screen required\nOther duties as assigned\nKNOWLEDGE, SKILLS & EXPERIENCE\n\nEDUCATION / CERTIFICATIONS / LICENSES\n\nEssential/Desired\n\nBS in Microbiology/ Biology, or related scientific discipline\n\nEssential\n\nON-THE-JOB EXPERIENCE\n\nAt least 8 years’ GMP Quality Control experience with at least 4 years management experience\n\nEssential\n\nAdvanced knowledge of global, especially US and EU GMP guidelines\n\nEssential\n\nSKILLS / ABILITIES\n\nStrong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence\n\nEssential\n\nConfident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards\n\nEssential\n\nStrong ability to prioritize and operate with a sense of urgency\n\nEssential\n\nSolid organizational, analytical and problem-solving skills\n\nEssential\n\nEffective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills\n\nEssential\n\nDemonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment\n\nEssential\n\nStrong operational and business acumen\n\nEssential\n\nExhibits highest integrity and committed to ethics and compliance standards\n\nEssential\n\nOpen and transparent in sharing data and information\n\nEssential\n\nCOMPENSATION RANGE\nThe compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:\n Manager- $130,00-$150,000\n Sr. Manager- $150,000-$170,000\nPHYSICAL DEMANDS\n While 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; use hands to finger, handle, or feel; reach with hands and arms\nOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl\nLifting\nFrequently lift and/or move up to 10 pounds\nOccasionally lift and/or move up to 25 pounds\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":8694,"description_truncated":false,"requirements":{"experience_years_min":8,"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":"2026-10-21T19:59:55Z"}],"visa":[],"liveness":{"score":85,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.845,"p_room":1,"age_days":14,"expected_fill_days":46,"reasons":["conf:3","win:early"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/genezen-managersenior-manager-quality-control-microbiology","json_url":"https://alion.io/job/genezen-managersenior-manager-quality-control-microbiology.json","meta":{"generated_at":"2026-11-05T08:21:49Z","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":10759,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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-managersenior-manager-quality-control-microbiology"},{"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-managersenior-manager-quality-control-microbiology"},{"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-managersenior-manager-quality-control-microbiology"},{"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-managersenior-manager-quality-control-microbiology\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenezen-managersenior-manager-quality-control-microbiology"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3029418}},{"tool":"search_jobs","arguments":{"company":"genezen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3029418},"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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