{"id":4054198,"url":"https://alion.io/job/sofie-biosciences-pharmaceutical-production-chemist-ii","title":"Pharmaceutical Production Chemist II","company":{"id":4480059,"name":"Sofie Biosciences","domain":"sofie.com","url":"https://alion.io/company/sofie-biosciences","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career site","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Totowa, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85000,"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":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-14T18:01:24Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-11T13:02:11Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"Description:Pharmaceutical Production Chemist II\nTitle | Pharmaceutical Production Chemist II\nLocation | Totowa, NJ\nDepartment | Radiopharmaceutical Contract Manufacturing\nReports To | Production Manager, Radiopharmaceutical Contract Manufacturing\nCompensation Range | $85,000 - $90,000\nOverview\nThe Pharmaceutical Production Chemist II will support the production of new therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE’s pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211).\nEssential Duties and Responsibilities\nOperate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment.\n\nPrepare materials/consumables for manufacturing processes and perform system checks on equipment before use in aseptic processes.\n\nPerform manufacturing activities in ISO-7 and ISO-5 environments.\n\nFollow detailed instructions in Master Batch Records and recognize and report any deviations from those instructions during batch manufacturing.\n\nPerform line clearance and pre-batch cleaning activities on the production line.\n\nLead and organize local production operators and other team members on the technological transfer of production processes (synthesis) utilized for sterile dug manufacturing.\n\nLead and execute the qualification of manufacturing processes, validation protocols, and manufacturing validations.\n\nPrepare SOPs for manufacturing/production activities and validation protocols for production processes and equipment including final reports.\n\nContribute to the production of multiple radiopharmaceutical products.\n\nInitiate and author Investigations, CAPAs, Deviation, and Change Control documentation as related to manufacturing of drug product including samples generated for testing of radiopharmaceuticals.\n\nFollow and observe all radiation safety procedures in agreement with regulatory licensing of radioactive material possession and handling. Provide related training to other staff members as required.\n\nParticipate in the qualification/validation campaign for new radiopharmaceutical process implementation according to GMP standards.\n\nMaintain approved gowning validation and media fill participation to allow access to classified manufacturing areas.\n\nMaintain a clean and safe working environment in compliance with hazardous material safety and pharmaceutical regulation.\n\nPerform radiation safety duties in compliance with regulations.\n\nPackages manufactured drug product for shipment to clinical sites.\n\nEfficiently comply with waste management rules and regulations.\n\nAttend internal and external meetings as required.\n\nOther assigned duties as required.\n\nMay require over-time work.\n\nQualifications\nBachelor’s degree in Chemistry, Biological, or Physical Science required with 2+ years of experience in manufacturing of radiopharmaceuticals (qualification, troubleshooting and maintenance) or equivalent combination.\n\nExperience in a GMP manufacturing environment required.\n\nExperience with the use of automated synthesis modules and maintenance of automated modules highly preferred.\n\nAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.\n\nKnowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification required.\n\nEfficient in the use of MS Office Suite required.\n\nAbility to be detail-oriented, accountable, patient, and work in a team environment with minimum supervision required. Individual must be capable of learning and understanding multiple disciplines. Individual must have previous HAZMAT worker compliance and/or Radiation Worker compliance experience, as occupational exposure to ionizing radiation within ALARA is part of the position.\n\nAbility to work multiple or staggered shifts required.\n\nAble to lift up to 50 lbs. preferred.\n\nTravel 10% required.","description_format":"text","description_chars":4049,"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":["Diagnostic Tests & IVD","Molecular Diagnostics"],"lifecycle":[{"event":"open","at":"2026-11-11T03:44:29Z"}],"visa":[],"liveness":{"score":43,"band":"fade","label":"Fading","p_open":1,"p_active":0.777,"p_room":0.55,"age_days":27,"expected_fill_days":26,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":90000,"is_top_pay":false},"html_url":"https://alion.io/job/sofie-biosciences-pharmaceutical-production-chemist-ii","json_url":"https://alion.io/job/sofie-biosciences-pharmaceutical-production-chemist-ii.json","meta":{"generated_at":"2026-11-11T13:47:47Z","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":25279,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"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":4480059},"rest":"https://alion.io/mcp/rest/get_company?id=4480059"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsofie-biosciences-pharmaceutical-production-chemist-ii"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fsofie-biosciences-pharmaceutical-production-chemist-ii"},{"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%2Fsofie-biosciences-pharmaceutical-production-chemist-ii"},{"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/sofie-biosciences-pharmaceutical-production-chemist-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsofie-biosciences-pharmaceutical-production-chemist-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4054198}},{"tool":"search_jobs","arguments":{"company":"sofie.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4054198},"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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