{"id":3692516,"url":"https://alion.io/job/sumitomo-pharma-manager-cgmp-manufacturing","title":"Manager, cGMP Manufacturing","company":{"id":1797163,"name":"Sumitomo Pharma","domain":"sumitomo-pharma.com","url":"https://alion.io/company/sumitomo-pharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Morrisville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-03T17:09:51Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-04T19:15:42Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.\nWe seek a dynamic, highly motivated, and experienced individual for the Manufacturing Manager, cGMP Manufacturing role. The Manufacturing Manager will ensure production readiness and compliance initiatives are optimized and executed appropriately in GMP production. This position will be onsite at the manufacturing facility in Morrisville, NC. This position is an exempt role and will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays. Weekends and holidays are required as scheduled.\nJob Duties and Responsibilities\nHire and develop a high-performing, flexible manufacturing team (approximately 5 operators) capable of meeting the manufacturing operation timeline. \nEnsure plans and resources (people, facilities, supplies etc.) are efficiently utilized for training and to manufacture RETHYMIC and future clinical programs for on time delivery. \nOversee the training, development, retention, and performance of staff for the execution of manufacturing operations. \nClosely partner with QA peers for creation of SOPs, closure of documentation, inclusive of training records, deviations, batch records and CAPAs, required for timely disposition of batches. \nEnsure smooth production operations through proactive scheduling and planning of activities. \nLead efforts in scheduling personnel for follow-up and emergency production work. \nResponsible for ensuring alarm monitoring, response, and reconciliation is performed in a timely fashion. \nAttend and actively participate in waste walkthroughs, 5S, Gemba walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives, as required. \nCoach operators in high quality deviation write-ups and appropriate CAPA development/effectiveness checks; drives manufacturing deviations to on-time closure and works with team to assure minimal deviations. \nSupport regular operation of manufacturing facility and responds to issues as needed. \nPrepare for and successfully participate in internal audits and FDA inspections. \nPrioritizes the work of others. \nPerforms other activities as required. \nKey Core Competencies\nClear communication is required with cross-functional peers daily. \nAbility to build strong, open, collaborative working relationships with internal and external stakeholders. \nSound knowledge of current Good Manufacturing Practices. \nExceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative required. \nStrong oral/written technical communication and leadership skills are required. \nAbility to work well with all levels of company personnel. \nAbility to work independently with minimal supervision. \nCapable of rapidly absorbing technical data and applying this knowledge to a pharmaceutical manufacturing environment. \nProblem-solving experience providing consistent judgment, quality, accuracy, speed, and creativity. \nTakes initiative in making improvement suggestions to promote operational goals.\nEducation and Experience\nA minimum of 5 years of relevant experience working in the pharmaceutical, biopharmaceutical, regenerative medicine, or medical device industry is required. \nMinimum 2 years of management or cross-functional project management experience in a professional setting.\nPrevious experience working in ISO 7 & 8 cleanrooms along with isolators is preferred. \nExperience at an FDA approved or late-stage cGMP manufacturing site. \nExperience in production batch record review, investigation of deviations, root cause analysis, effective CAPA development, good documentation practices, and change control management.\nExperience delivering consistently prompt, efficient, dependable, highly skilled service to multiple stakeholders.\nBachelor's degree in science or engineering, or a degree in a relevant technical trade, is required.\nBackground in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired.\nTravel Requirements:\nEmployees based onsite may need to travel domestically and/or internationally up to 10-25% of the time as required. Additional travel may be required for Management roles.\nMental/Physical Requirements:\n1. Lifting and Carrying: Ability to lift and carry materials, including heavy items, as part of daily operations.\n2. Standing and Walking: Prolonged periods of standing and walking\n3. Manual Dexterity: Handling and operating equipment and tools.\n4. Climbing and Reaching: Ability to climb ladders or steps and reach for items stored at various heights.\n5. Environmental Conditions: Working in varying temperatures and handling materials in different environmental conditions.\nThe base salary range for this role is\n$120,000.00 - $150,000.00Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.\nDisclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.\nConfidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.\nCompliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the \"best\" industry practices and the highest ethical standards.\nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.\nDrug Screening Requirements\nApplicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.\nSumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer\nQualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nSumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.","description_format":"text","description_chars":8446,"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":true,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-03T17:09:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 19 · green card filings: 3","filings_12m":19,"filings_prev_12m":5,"green_card_filings_12m":3,"median_offered_wage_usd":166818,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":22,"reasons":["conf:1","win:early"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/sumitomo-pharma-manager-cgmp-manufacturing","json_url":"https://alion.io/job/sumitomo-pharma-manager-cgmp-manufacturing.json","meta":{"generated_at":"2026-11-05T02:39:45Z","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":3429,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":1797163},"rest":"https://alion.io/mcp/rest/get_company?id=1797163"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsumitomo-pharma-manager-cgmp-manufacturing"},{"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%2Fsumitomo-pharma-manager-cgmp-manufacturing"},{"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%2Fsumitomo-pharma-manager-cgmp-manufacturing"},{"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/sumitomo-pharma-manager-cgmp-manufacturing\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsumitomo-pharma-manager-cgmp-manufacturing"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3692516}},{"tool":"search_jobs","arguments":{"company":"sumitomo-pharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3692516},"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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