{"id":4272951,"url":"https://alion.io/job/catalent-scientist-process-development-drug-substance-lifecycle","title":"Scientist – Process Development, Drug Substance Lifecycle","company":{"id":1785256,"name":"Catalent","domain":"catalent.com","url":"https://alion.io/company/catalent-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Science & Research","role_family":"Science & Research","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":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"JMP","optional":true},{"name":"Minitab","optional":true}],"status":"live","first_seen_at":"2026-11-13T18:24:59Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-13T18:24:59Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Scientist - Process Development, Drug Substance Lifecycle\nCatalent is seeking a Scientist - Process Development, Drug Substance Lifecycle to join our team in Madison, Wisconsin. In this role, you will provide technical expertiseand lifecycle support for biologics programs as they progress through development, validation, commercialization, and post-approval manufacturing. You'llcollaborate across Manufacturing, Quality, MS&T, Regulatory, Project Management, and client teams to drive successful program execution and continuous process improvement.\nAbout Catalent Madison: Catalent's Madison, Wisconsin facility is a state-of-the-artbiologicsdevelopment and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development.\nThe site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologicsnetwork while supporting Wisconsin's growing life sciences industry.\nLocation: 100% Onsite at our facility in Madison, Wisconsin\nShift: Monday - Friday, First Shift\nKey Responsibilities:\nLead process characterization activities for development, validation, and commercial-stage biologics programs.\n\nSupport process validation, continued process verification, comparability assessments, and lifecycle change management.\n\nAnalyze process performance data, identifyimprovement opportunities, and drive risk reduction initiatives.\n\nServe as a technical subject matter expert for assigned programs and client interactions.\n\nAuthor and review technical protocols, reports, validation documents, and regulatory support documentation.\n\nSupport investigations, CAPAs, change controls, and quality system activities in a cGMP environment.\n\nCollaborate with cross-functional teams to ensure successful technology transfer and commercial manufacturing support.\n\nOther responsibilities as needed.\n\nRequired Qualifications:\nPhD in a STEM discipline or Master'sdegree with a minimum of 3 years of relevant industry experience;or Bachelor'sdegree with a minimum of 6 years of relevant industry experience.\n\nPreferred Qualifications:\nExperience supporting biologicsdevelopment, characterization, validation, or commercial manufacturing.\n\nKnowledge of process characterization, PPQ, lifecycle management, and validation principles.\n\nExperience working within cGMPenvironments.\n\nFamiliarity with statistical analysis tools such as JMP, Minitab, or Excel.\n\nExperience supporting cross-functional technical projects and client-facing activities.\n\nWhy you should join Catalent:\nOpportunity to play a key role in driving growth within a global CDMO leader.\n\nCompetitive compensation package, including incentive opportunity.\n\nDay-one medical, dental, and vision coverage.\n\n401(k) with company match.\n\nTuition reimbursement and professional development opportunities.\n\nGenerous paid time off and holiday schedule (152 hours+ 8 holidays)\n\nCollaborative, mission-driven culture focused on improving patient outcomes worldwide.\n\nCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.\npersonal initiative. dynamic pace. meaningful work.\nVisit Catalent Careers to explore career opportunities.\nCatalent is an Equal Opportunity Employer, including disability and veterans.\nIf you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.\nNotice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.\nImportant Security Notice to U.S. Job Seekers:\nCatalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to  for us to investigate with local authorities.\nCalifornia Job Seekers can find our California Job Applicant Notice HERE.\nVolunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.\nMassachusetts Lie Detector Test Notice: It 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 may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.","description_format":"text","description_chars":6392,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dietary Supplements","Contract Manufacturing","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-13T18:24:59Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":33,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-11-13T20:34:57Z"},"pay":null,"html_url":"https://alion.io/job/catalent-scientist-process-development-drug-substance-lifecycle","json_url":"https://alion.io/job/catalent-scientist-process-development-drug-substance-lifecycle.json","meta":{"generated_at":"2026-11-13T20:34:57Z","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":41017,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"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":1785256},"rest":"https://alion.io/mcp/rest/get_company?id=1785256"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcatalent-scientist-process-development-drug-substance-lifecycle"},{"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%2Fcatalent-scientist-process-development-drug-substance-lifecycle"},{"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%2Fcatalent-scientist-process-development-drug-substance-lifecycle"},{"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/catalent-scientist-process-development-drug-substance-lifecycle\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcatalent-scientist-process-development-drug-substance-lifecycle"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4272951}},{"tool":"search_jobs","arguments":{"company":"catalent.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4272951},"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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