{"id":253621,"url":"https://alion.io/job/orca-bio-manufacturing-process-lead-3rd-shift","title":"Manufacturing Process Lead (3rd Shift)","company":{"id":4299,"name":"Orca Bio","domain":"orcabio.com","url":"https://alion.io/company/orca-bio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":80,"open_postings":13,"ghost_share":0,"stale_share":0.615,"repost_share":0,"time_to_fill_p50_days":75,"computed_at":"2026-10-24T06:02:35Z"}},"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":["Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":70000,"max":90000,"currency":"USD","period":"year","gross":null,"usd_annual":90000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-07-20T21:54:37Z","employer_posted_date":"2026-07-20","last_verified_at":"2026-10-24T12:35:00Z","board_verified":true,"closed_at":null,"days_open":95,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":95},"description":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\nWe are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\nThe Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives.\nEssential Duties & Key Responsibilities:\nOversee execution of routine manufacturing and occasional scientific protocols\nDevelop and refine procedures for cell separation technologies, sterile connections, and aseptic techniques\nServe as subject matter expert for cell therapy processes and new technology\nProvide verification for results and ensure detailed records are maintained\nPrepare, maintain, trouble-shoot, and operate instruments\nPlan the shift - including break management, shift pass downs, and process appropriate decisions\nSupervise in-room operations and delegate individual tasks based on operator capacity\nComplete deviations\nEscalate issues appropriately\nReview and support continuous improvements of business processes, records, and SOPs\nTraining and coaching employees\nOther duties as assigned\nMinimum Qualifications:\nBachelor’s degree in a science related field (Biology, engineering, etc.) or related field, required. Master’s degree preferred\n2-3 years of experience in GMP Manufacturing, process sciences, or discovery \nExperience with aseptic techniques \nFamiliarity with cell/or gene therapy, including working with human cells, cell characterization methods, or cell separation techniques\nDirect or indirect people leadership preferred\nFlexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.\n3rd Shift:\nMonday - Friday, 12:00am - 8:30am\nPhysical Demands\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.","description_format":"text","description_chars":3664,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-05T11:13:36Z"}],"visa":[],"liveness":{"score":21,"band":"cold","label":"Long shot","p_open":1,"p_active":0.48,"p_room":0.44,"age_days":95,"expected_fill_days":75,"reasons":["conf:2","stale_co","win:tail","crowd:"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":90000,"is_top_pay":false},"html_url":"https://alion.io/job/orca-bio-manufacturing-process-lead-3rd-shift","json_url":"https://alion.io/job/orca-bio-manufacturing-process-lead-3rd-shift.json","meta":{"generated_at":"2026-10-24T14:39:07Z","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":20779,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":4299},"rest":"https://alion.io/mcp/rest/get_company?id=4299"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Forca-bio-manufacturing-process-lead-3rd-shift"},{"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%2Forca-bio-manufacturing-process-lead-3rd-shift"},{"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%2Forca-bio-manufacturing-process-lead-3rd-shift"},{"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/orca-bio-manufacturing-process-lead-3rd-shift\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Forca-bio-manufacturing-process-lead-3rd-shift"}]}