Senior Scientist I - Quality Control - Data Review

Senior Scientist I - Quality Control - Data ReviewPosition Summary:Shift: M-F 8am-5pmLocation: Madison, WI100% OnsiteCatalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx and GPEx Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.We have an opportunity for a Senior Scientist I - Quality Control - Data Review to join our team. In this role, you will execute and document cGMP Quality Control testing with precision. You will operate equipment, review analytical data, and ensure compliance with SOPs. You will also contribute to technical documentation and support laboratory operations in a collaborative environment.The Role:Review a variety of different testsReview and update Standard Operating Procedures (SOPs)Perform monthly routine checks of logbooks within the labEnsure adherence to protocols and methodsFollow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)Review analytical and microbiology dataAssist with training of junior staffHelp coordinate day-to-day tasks in the supervisor’s absenceAll other duties as assigned.The Candidate:Ph.D. in Biology, Biotechnology, Chemistry or related life sciences field ORMaster’s degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience ORBachelor’s degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience ORAssociate degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience ORHigh School Diploma or equivalent with a minimum of 11 years of industry experienceIntermediate to advanced proficiency in Microsoft Office preferredFamiliarity with EMPOWER software preferredPreferred Skills & BackgroundExperience with EMPOWER system used for High-Performance Liquid Chromatography (HPLC)Strong background in Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), and Reverse Phase High-Performance Liquid Chromatography (RP-HPLC)Experience with Enzyme-Linked Immunosorbent Assay (ELISA) and plate-based assaysKnowledge of compendial methods, appearance, pH, concentration, and osmolalityWhy You Should Join CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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. personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If 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 View email address on click.appcast.io. 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.Notice 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.Important Security Notice to U.S. Job Seekers:Catalent 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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Madison, WIType: Full time