Associate - Biomanufacturing, Upstream

Catalent • Madison, WI

3d • Onsite

About The Position

The Associate - Biomanufacturing, Upstream performs upstream cell culture activities, including aseptic manipulation, large-scale cell culture, bulk harvest clarification, and cell bank vialing. The role executes manufacturing processes accurately and in compliance with current Good Manufacturing Practice (cGMP) standards, contributes to continuous improvement initiatives, and supports team development through training and collaboration. The position is 100% onsite at Catalent’s Madison, Wisconsin site and works Sunday through Wednesday, 2:00 PM to 12:00 AM.

Catalent’s Madison site is a biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. The approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, using flexible single-use systems. Production scales range from 50 to 4,000 liters for clinical manufacturing.

Requirements

• Master’s degree in a scientific, engineering, or biomanufacturing discipline with no experience required; or a bachelor’s or associate’s degree in one of these disciplines with at least 1 year of relevant experience; or a high school diploma with at least 4 years of relevant experience.
• Must comply with the position’s EHS responsibilities.
• Ability to operate in a clean room environment as needed.

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.
• 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 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, and proactively identify safety, quality, and efficiency improvements.
• Participate in the Catalent Way continuous improvement culture, lead Just Do It initiatives, and support implementation of continuous improvement projects.
• Coach junior team members and support new employee onboarding.
• May become a Certified Trainer responsible for final sign-off of training completion for basic execution activities.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Competitive paid time off and 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED