{"id":3657036,"url":"https://alion.io/job/seran-bioscience-project-manager-cgmp-commercial-readiness","title":"Project Manager, cGMP Commercial Readiness","company":{"id":686143,"name":"Serán Bioscience","domain":"seranbio.com","url":"https://alion.io/company/seranbio","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"A","score":95,"open_postings":11,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":97,"computed_at":"2026-11-15T07:52:55Z"}},"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":["Bend, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-02T21:59:51Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-15T16:59:54Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"Serán BioScience provides optimized drug development and manufacturing services from discovery through clinical stages. An expansion is currently underway to provide commercial manufacturing capabilities in 2027. The company uses a science-driven approach, combining predictive design tools, advanced chemistry, analytical capabilities, and enabling delivery technologies with strong quality and regulatory expertise.\nThe Project Manager, Commercial Readiness serves as the central coordinator for cross-functional readiness activities and is responsible for ensuring organizational preparedness for upcoming commercial manufacturing operations. This role drives accountability, visibility, risk management, and execution of readiness plans across Quality, Manufacturing, Technical Operations, Supply Chain, Validation, Regulatory Affairs, and supporting functions. The position does not directly manage functional resources but is responsible for facilitating alignment and timely completion of readiness deliverables.\nCommercial Readiness Program Leadership\nDevelop and maintain integrated commercial readiness plans.\nCoordinate readiness activities across all cGMP and supporting functions.\nEstablish readiness milestones, deliverables, and decision gates.\nMonitor progress against commercial readiness objectives.\nIdentify program risks and facilitate development of mitigation strategies.\nEnsure readiness activities remain aligned with business objectives and client commitments.\nProduct Launch & Technology Transfer Support\nCoordinate readiness activities supporting product launches.\nSupport cross-functional planning for technology transfers.\nEnsure required systems, procedures, personnel, and facilities are available to support manufacturing activities.\nTrack critical path activities and assess launch readiness.\nProcess Performance Qualification (PPQ) Readiness\nCoordinate PPQ readiness assessments.\nEnsure departments complete required deliverables before execution.\nFacilitate readiness reviews and gap assessments.\nSupport development of post-PPQ action plans and lessons learned initiatives.\nCommercial Manufacturing Readiness - Coordinate readiness activities for:\nProcess Performance Qualification (PPQ)\nCommercial product launch\nTechnology Transfer\nInspection Readiness\nManufacturing Readiness\nLaboratory Readiness\nSupply Chain Readiness\nTraining Readiness\nValidation Readiness\nQuality System Readiness\nClient Onboarding\nRegulatory Commitments\nGovernance & Executive Reporting\nDevelop executive-level readiness dashboards.\nPrepare status updates for leadership review.\nFacilitate readiness steering committee meetings.\nTrack action items and accountability commitments.\nCommunicate critical risks and recommendations to leadership.\nEscalate critical issues to leadership.\nDrive accountability for milestone completion across functional teams.\nRisk Management\nMaintain commercial readiness risk registers.\nEvaluate risks impacting launch timelines, client deliverables, compliance, quality, and operational execution.\nFacilitate risk assessments with cross-functional teams.\nMonitor effectiveness of mitigation plans.\nContinuous Improevment\nDevelop standardized readiness tools, templates, and methodologies.\nCapture lessons learned from launches and major programs.\nImprove organizational readiness planning processes.\nPromote project management best practices.\nRequired Skills & Abilities\nStrong project and program management skills.\nExcellent organizational and planning capabilities.\nAbility to manage multiple complex initiatives simultaneously.\nStrong facilitation and leadership skills.\nAbility to influence without direct authority.\nExceptional written and verbal communication skills.\nStrong risk management and problem-solving capabilities.\nAbility to operate effectively in highly cross-functional environments.\nWorking knowledge of pharmaceutical development, manufacturing, and quality systems.\nProficient with Microsoft Office Suite or related software for project tracking\nPreferred Qualifications\nCDMO experience.\nCommercial manufacturing experience.\nProduct launch experience.\nProcess Performance Qualification (PPQ) experience.\nRegulatory inspection experience.\nExperience implementing organizational readiness programs.\nEducation & Experience\nBachelor's degree in Life Sciences, Engineering, Business, Project Management, or related discipline preferred. High School Diploma required.\n7-10 years of experience in regulated GMP manufacturing environment. \nExperience supporting commercial manufacturing, product launches, PPQ programs, technology transfers, or large-scale GxP projects.\nDemonstrated success leading complex cross-functional initiatives.\nPMP certification required. \nPhysical Requirements\nProlonged periods of sitting or standing at a desk and working on a computer\nMust be able to lift up to 15 pounds at a time\nAdheres to consistent and predictable in-person attendance","description_format":"text","description_chars":4926,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-03T02:17:01Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":12,"expected_fill_days":97,"reasons":["conf:3","win:early"],"computed_at":"2026-11-15T07:52:55Z"},"pay":null,"html_url":"https://alion.io/job/seran-bioscience-project-manager-cgmp-commercial-readiness","json_url":"https://alion.io/job/seran-bioscience-project-manager-cgmp-commercial-readiness.json","meta":{"generated_at":"2026-11-15T20:58:20Z","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":15775,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"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":686143},"rest":"https://alion.io/mcp/rest/get_company?id=686143"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fseran-bioscience-project-manager-cgmp-commercial-readiness"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fseran-bioscience-project-manager-cgmp-commercial-readiness"},{"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%2Fseran-bioscience-project-manager-cgmp-commercial-readiness"},{"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/seran-bioscience-project-manager-cgmp-commercial-readiness\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fseran-bioscience-project-manager-cgmp-commercial-readiness"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3657036}},{"tool":"search_jobs","arguments":{"company":"seranbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3657036},"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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