Senior Scientist I Quality Control Data Review

Senior Scientist I - Quality Control - Data Review

Position Summary:

• Shift: M-F 8am-5pm
• Location: Madison WI
• 100% Onsite

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 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 Catalents global biologics network and Wisconsins growing life sciences ecosystem.

We have an opportunity for a Senior Scientist I - Quality Control - Data Review to join our 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 tests
• Review and update Standard Operating Procedures (SOPs)
• Perform monthly routine checks of logbooks within the lab
• Ensure adherence to protocols and methods
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review analytical and microbiology data
• Assist with training of junior staff
• Help coordinate day-to-day tasks in the supervisors absence
• All other duties as assigned.
  

The Candidate:

• Ph.D. in Biology Biotechnology Chemistry or related life sciences field OR
• Masters degree in Biology Biotechnology Chemistry or related life sciences field with a minimum of 4 years of industry experience OR
• Bachelors degree in Biology Biotechnology Chemistry or related life sciences field with a minimum of 6 years of industry experience OR
• Associate degree in Biology Biotechnology Chemistry or related life sciences field with a minimum of 10 years of industry experience OR
• High School Diploma or equivalent with a minimum of 11 years of industry experience
• Intermediate to advanced proficiency in Microsoft Office preferred
• Familiarity with EMPOWER software preferred

Preferred Skills & Background

• Experience 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 assays
• Knowledge of compendial methods appearance pH concentration and osmolality

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical dental and vision benefits effective day one of employment
• Tuition reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.

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