Associate - Biomanufacturing, Upstream
About The Position
The Associate - Biomanufacturing, Upstream performs upstream cell culture activities at Catalent’s Madison, Wisconsin biologics development and manufacturing facility. The role includes aseptic manipulation, large-scale cell culture, bulk harvest clarification, and cell bank vialing. Work is performed in compliance with cGMP requirements, with emphasis on accurate, right-first-time execution and documentation. The associate also supports continuous improvement and contributes to team development through collaboration and training. The position is 100% onsite in Madison, Wisconsin, on a Sunday–Wednesday shift from 2:00 PM to 12:00 AM. The facility is a controlled HVAC environment, and the role may require work in a clean room. Catalent’s Madison site supports biologics development and clinical manufacturing, including mammalian cell line engineering and drug substance biomanufacturing, with production scales from 50 to 4,000 liters. The site uses flexible single-use systems and Catalent’s GPEx® and GPEx® Lightning technologies.
Requirements
- Master’s degree in a scientific, engineering, or biomanufacturing discipline; no experience required; OR bachelor’s or associate’s degree in one of these disciplines and at least 1 year of relevant experience; OR high school diploma and at least 4 years of relevant experience.
- Ability to perform the physical activities described, including frequent lifting or moving of up to 10 pounds and occasional lifting or moving of up to 50 pounds.
- Ability to operate in a clean room environment as needed.
- Ability to work the stated Sunday–Wednesday shift, 2:00 PM–12:00 AM, onsite in Madison, Wisconsin.
Nice To Haves
- GMP experience.
- Experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and chromatography software such as Unicorn.
Responsibilities
- 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 activities according to 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, and identify safety, quality, and efficiency improvements.
- Participate in Catalent Way continuous improvement, lead Just Do It initiatives, and support implementation of continuous improvement projects.
- Coach junior team members, support new employee onboarding, and potentially serve as a Certified Trainer responsible for final sign-off of training completion for basic execution activities.
- Comply with EHS responsibilities for the position.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Defined career path and annual performance review and feedback process.
- Potential for career growth on an expanding team.
- Diverse, inclusive culture.
- Community engagement and green initiatives.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
