{"id":1322902,"url":"https://alion.io/job/elevatebio-senior-manager-qc-technical-operations","title":"Senior Manager, QC Technical Operations","company":{"id":3157164,"name":"ElevateBio","domain":"elevate.bio","url":"https://alion.io/company/elevate-bio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"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":"structured","locations":["Pittsburgh, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":104000,"max_usd":198000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5037},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-15T16:07:01Z","employer_posted_date":"2026-09-18","last_verified_at":"2026-10-12T17:11:31Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.\nThe Role\nElevateBio is looking for an outstanding candidate to represent Quality Control in our Pittsburgh facility. Initially, this role will be focused on execution of the Quality Control site startup plan and associated projects needed to prepare our new facility for clinical and commercial manufacturing for US and EU markets. You’ll work collaboratively with the core team, internal subject matter experts, and external project team members to develop and implement procedural changes, digital systems, and business processes at the site according to a defined project plan. This role will also assist with establishing the microbiology function in Pittsburgh to support laboratory/clean room start-up and qualification. In operation, the position will transition to oversight of quality control functions including but not limited to documents, training, metrics, investigations, functional projects, and logistics/outsourcing and may support on-floor lab operations as needed to meet business goals. Candidates should have extensive experience in a GMP manufacturing facility. This role is based on site in Pittsburgh. \nHere’s What You’ll Do\nOwn quality control procedure revisions to reflect desired business processes. Support/review other functional documentation including protocols and reports.\nPartner with MSAT on plans for initial tech transfer support and program onboarding\nAssist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.\nSupport planning and implementation of site training program and implementation of EM and aseptic programs\nReview, trend and present data to senior management\nOversee laboratory excursions, including; deviations, OOS, OOT and atypical investigations\nParticipate in regulatory inspections and facility audits\nHire, train and mentor staff\nRequirements:\nBachelor’s degree and at least 8 years of experience, OR Master’s degree with 6 years of experience, OR PhD with at least 4 years of experience.\nExperience supervising teams of people.\nExperience with clean room qualification per ISO 14644\nExperience with compendial safety testing as well as rapid methodologies (BacT)\nExperience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).\nExperience working with electronic systems (LIMS, CMMS, QMS, ERP).\nAbility to communicate and work independently with scientific/technical personnel.\nStrong knowledge of GMP, SOPs, and quality system processes. \nExcellent organizational skills.\nExperience in cell and gene therapy manufacturing environment a plus\nExperience performing laboratory investigations\nPhysical and Environment Requirements:\nAbility to stand, walk, bend and stretch for extended period of time\nAbility to lift 15-20 lbs\nAbility to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.\nAbility to perform routine repetitive motions with use of arms, wrists and hands\nAbility to work nights, weekends, and holidays as needed to support business needs.\n\nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. 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