{"id":768382,"url":"https://alion.io/job/genefab-program-manager-crdmo","title":"Program Manager, CRDMO","company":{"id":674418,"name":"GeneFab","domain":"genefab.com","url":"https://alion.io/company/genefab","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":140000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Smartsheet","optional":true}],"status":"live","first_seen_at":"2026-08-11T23:20:36Z","employer_posted_date":"2026-08-11","last_verified_at":"2026-11-05T23:19:13Z","board_verified":true,"closed_at":null,"days_open":86,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":86},"description":"We are seeking a Program Manager to drive cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) programs within an Integrated Project Delivery (IPD) framework. This role supports the full product development lifecycle - from biological design and process development through pivotal manufacturing and regulatory submission - operating as a shared-accountability leader embedded within a unified, cross-functional project team. The ideal candidate brings deep technical expertise, a collaborative leadership style, and the agility to co-own outcomes with sponsors, internal partners, and external parties under IPD principles of transparency, early risk surfacing, and joint decision-making.\nKey Responsibilities: IPD Program Leadership & Governance\nLead the workstream within the Integrated Project Team (IPT), co-owning program outcomes with Synthetic Biology, Process Development, Analytical Development, MSAT, Quality Control, GMP Manufacturing, Regulatory Affairs, Finance and sponsor partners.\nFacilitate IPT working sessions and Joint Steering Committee (JSC) meetings; frame decisions with full context, scenario analysis, and downstream impact.\nChampion IPD principles: shared risk/reward, open-book collaboration, and joint decision-making across all workstreams.\nDrive escalation to governance committees at the right level and time; iterate on PMO frameworks, risk registers, and project review boards to improve oversight.\nKey Responsibilities: Project Execution (Customer oriented and internal R&D)\nLead end-to-end program execution, including therapeutic design, process and analytical development, pivotal readiness, method qualification/validation, pilot & engineering run strategies, and regulatory submission readiness.\nDrive cross-functional alignment across SynBio, PD, AD, MSAT, QC, and GMP Manufacturing to ensure process consistency, data integrity, and regulatory compliance.\nTranslate technical data into program decisions with clear traceability to TPPs, CQAs, CPPs, and regulatory expectations.\nOrchestrate knowledge transfer at key project stages, including onboarding new intellectual property, technology transfer from PD to GMP Manufacturing, and handoffs between customers and internal teams and third party partners in real time.\nCo-lead CMC regulatory strategy with Regulatory Affairs; own the CMC content roadmap and ensure data packages are submission-ready for IND, IMPD, BLA/MAA, or applicable filings.\nServe as primary point of contact for sponsors and clients; lead integration sessions that bring sponsor teams into the delivery process as active IPD participants.\nManage scope, deliverables, and expectations, lead change order and scope modification discussions in collaboration with Business Development and technical leads.\nTrack program budgets, resource forecasts, and milestone-based invoicing using IPD cost-transparency practices for real-time financial visibility.\nIdentify, quantify, and manage technical, regulatory, and timeline risks; develop scenario-based mitigation strategies and advocate for resources (personnel, equipment, capacity) as needed.\nQualifications\nBachelor’s degree (required) in Life Sciences, Bioengineering, Chemical Engineering, or related field; advanced degree (MBA/M.S./Ph.D.) is nice to have.\n5-8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy across the full CMC lifecycle. Experience supporting IP, IND, BLA, MAA, or IMPD submissions.\nDemonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience strongly preferred.\nTrack record leading cross-functional product development projects (SynBio, PD, AD, MSAT, MFG, QC,)\nPMP certification, IPD, Lean, or Alliance Management training a plus.\nProficiency with Smartsheet Advance, ThinkCell, and integrated scheduling platforms; strong quantitative, risk modeling, and KPI design skills.\nProven ability to lead without direct authority in a matrixed, shared-accountability environment; excellent communication, facilitation, and negotiation skills.\nHigh adaptability and emotional intelligence; comfortable with fast-paced, distributed, cross-functional settings.","description_format":"text","description_chars":4243,"description_truncated":false,"requirements":{"experience_years_min":5,"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":["Synthetic Biology","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-11T20:42:14Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.587,"p_room":0.28,"age_days":85,"expected_fill_days":30,"reasons":["conf:2","win:tail","crowd:"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":200000,"is_top_pay":true},"html_url":"https://alion.io/job/genefab-program-manager-crdmo","json_url":"https://alion.io/job/genefab-program-manager-crdmo.json","meta":{"generated_at":"2026-11-06T01:25:58Z","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":2352,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":674418},"rest":"https://alion.io/mcp/rest/get_company?id=674418"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenefab-program-manager-crdmo"},{"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%2Fgenefab-program-manager-crdmo"},{"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%2Fgenefab-program-manager-crdmo"},{"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/genefab-program-manager-crdmo\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenefab-program-manager-crdmo"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":768382}},{"tool":"search_jobs","arguments":{"company":"genefab.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":768382},"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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