{"id":3007298,"url":"https://alion.io/job/prokidney-associate-director-raw-materials-msat","title":"Associate Director, Raw Materials MSAT","company":{"id":7427,"name":"ProKidney","domain":"prokidney.com","url":"https://alion.io/company/prokidney","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Winston-Salem, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":155000,"max_usd":269000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":375},"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-28T19:21:40Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-28T12:26:49Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"The Associate Director, Raw Materials Lead is accountable for establishing and leading the technical strategy, governance framework, and lifecycle management program for raw materials used in GMP manufacturing. The role translates CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier technical requirements, and ongoing performance monitoring.\nThis individual will serve as a key technical leader supporting BLA readiness, process validation, commercial launch preparation, and pre-license inspection (PLI) activities.\nKey Responsibilities\nDevelop and implement strategic frameworks for raw material knowledge transfer and lifecycle management\nLead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturability\nPartner with Quality Assurance and Supply Chain to define the technical elements of supplier qualification, supplier monitoring, change notification assessment, and supplier corrective action plans.\nEstablish and manage the extractable/leachables program using risk based methodologies with external partners\nEstablish and govern the cGMP visual inspection program, including defect standards, sampling approaches, training requirements, escalation criteria, and trend review.\nDefine critical material attributes and their linkage to process performance and robustness\nAct as the subject matter expert on raw material science within CMC technical teams\nConduct risk assessments, supplier evaluations, and manage post-approval changes related to raw materials\nCollaborate on regulatory submissions and health authority interactions regarding material science topics\n\nInvestigations, CAPA & Quality Systems\nEnsure timely, science-based root cause analysis and effective CAPA implementation for raw material related deviations and proactive initiatives\nReview deviations, change controls, and risk assessments impacting raw material operations, including vendor notifications\nDrive continuous improvement initiatives to strengthen robustness of raw material program.\nCross-Functional Leadership\nPartner closely with:\nManufacturing Operations\nQuality Assurance\nQC Microbiology\nMSAT\nFacilities & Engineering\nSupply Chain\nRegulatory Affairs\nSupport strategic planning for commercial manufacturing readiness and network expansion.\nTeam Leadership\nBuild and lead high-performing raw material team focused on risk mitigation strategies\nDevelop training programs focused on:\nMaterial Qualification\nIn-coming receipt, inspection and testing\ncGMP cleanroom practices\nFoster a strong quality culture emphasizing proactive risk identification and operational discipline.\nQualifications\nEducation\nBachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.\nAdvanced degree preferred.\nExperience\n10+ years of experience in biologics or cell and gene therapy (CGT),\nSignificant experience supporting autologous cell therapy, CGT or other patient-specific manufacturing operations strongly preferred.\nDemonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation.\nDeep knowledge of CMC processes for biologics, CGT or Cell Therapy platforms, including technology transfer and lifecycle management\nProven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturing\nStrong organizational, problem-solving, and communication skills with the ability to influence decisions across teams\nExperience with commercial product lifecycle management including post-approval changes and supplier updates\nComprehensive understanding of cGMP requirements and regulatory expectations related to raw materials\nLeadership Competencies\nStrong executive communication and inspection interaction skills\nAbility to influence across Quality, Manufacturing, and Technical Operations\nStrategic systems-thinking capability\nStrong operational judgment under high-pressure manufacturing conditions\nAbility to build a proactive culture around continuous improvement\nMay lead a team of engineers/scientists\nExcellent mentoring and organizational leadership skills\nExhibit TRAC Leadership values\nProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\nApplicants must be eligible to work in the United States without the need for work visa or residency sponsorship.","description_format":"text","description_chars":4697,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Natural Resources","Cell & Gene Therapy","Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-10-21T14:15:12Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":107500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.838,"p_room":0.75,"age_days":29,"expected_fill_days":36,"reasons":["conf:3","win:late"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/prokidney-associate-director-raw-materials-msat","json_url":"https://alion.io/job/prokidney-associate-director-raw-materials-msat.json","meta":{"generated_at":"2026-10-28T15:35:07Z","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":20992,"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":7427},"rest":"https://alion.io/mcp/rest/get_company?id=7427"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprokidney-associate-director-raw-materials-msat"},{"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%2Fprokidney-associate-director-raw-materials-msat"},{"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%2Fprokidney-associate-director-raw-materials-msat"},{"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/prokidney-associate-director-raw-materials-msat\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprokidney-associate-director-raw-materials-msat"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3007298}},{"tool":"search_jobs","arguments":{"company":"prokidney.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3007298},"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. Docs: https://alion.io/developers"}}