Associate - Biomanufacturing, Upstream

Associate - Biomanufacturing, Upstream

About Site

Catalent’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.

Position Summary

We have an opportunity for an Associate - Biomanufacturing, Upstream to join our team. This role involves performing upstream cell culture activities, including aseptic manipulation, large-scale cell culture, and bulk harvest clarification. The position focuses on executing manufacturing processes accurately and in compliance with cGMP standards. The successful candidate will contribute to continuous improvement initiatives and support team development through training and collaboration.

Shift: Sun-Wed, 2:00 PM – 12:00 AM Location: Madison, WI 100% Onsite

The Role

• Perform basic upstream cell culture activities, including aseptic manipulation in Grade A environments, large-scale cell culture using single-use bioreactors, bulk harvest clarification, and cell bank vialing.
• Perform basic troubleshooting during aseptic processing, large-scale cell culture, and bulk harvest clarification activities.
• Accurately execute Manufacturing Batch Production Records and Standard Operating Procedures in compliance with current Good Manufacturing Practice requirements, emphasizing right-first-time execution.
• Document all activities in accordance with Good Documentation Practices, including batch records, forms, and other quality documentation.
• Identify deviations from intended procedures and promptly escalate concerns through the Rapid Response process.
• Evaluate procedures for opportunities to improve format, clarity, delivery, and process flow while proactively identifying safety, quality, and efficiency improvements.
• Actively participate in the Catalent Way continuous improvement culture, lead Just Do It initiatives, and support the implementation of continuous improvement projects.
• Provide coaching to junior team members, support new employee onboarding, and may become a Certified Trainer responsible for final sign-off of training completion for basic execution activities.

The Candidate

Minimum Requirements

• Master’s Degree in a scientific, engineering, or biomanufacturing discipline with no experience required, OR
• Bachelor’s or Associate’s Degree in a scientific, engineering, or biomanufacturing discipline with a minimum of 1 year of relevant experience, OR
• High School Diploma with a minimum of 4 years of relevant experience.

Preferred Skills & Background

• GMP experience preferred.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software (i.e. Unicorn).

Physical requirements: This position requires frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

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 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.

Note: Catalent is an Equal Opportunity Employer, including disability and veterans.