Associate - Biomanufacturing, Upstream

Catalent • Madison, WI

3d • Onsite

About The Position

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. The approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development. It uses flexible single-use systems and supports clinical manufacturing at scales from 50 to 4,000 liters.

The Associate - Biomanufacturing, Upstream performs upstream cell culture activities and basic troubleshooting in a controlled environment, following established procedures and documentation standards to ensure compliance and quality. The role contributes to continuous improvement and production of biologic therapies. It is based 100% onsite in Madison, Wisconsin, and follows one of two schedules: Sunday through Wednesday or Wednesday through Saturday, 6 a.m. to 4 p.m.

Requirements

• High school diploma or equivalent and at least four years of relevant experience; or an Associate or Bachelor’s degree in a scientific, engineering, or biomanufacturing discipline and at least one year of experience; or a Master’s degree in Science, Technology, Engineering, or Mathematics without formal experience.
• Ability to use Microsoft Word, Excel, and other Office systems.
• Ability to operate in a cleanroom environment as needed.
• Ability to perform the physical activities described, including frequent sitting, standing, walking, reading, computer-monitor use, reaching, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping; frequent lifting or moving up to 10 pounds and occasional lifting or moving up to 50 pounds.

Nice To Haves

• Experience in Good Manufacturing Practice manufacturing.
• Experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and chromatography software such as Unicorn.

Responsibilities

• Perform basic troubleshooting and upstream cell culture activities, including aseptic manipulation in a Grade A environment, large-scale culture in single-use bioreactors, clarification of bulk harvest product, and cell bank vialing.
• Follow Manufacturing Batch Production Records and Standard Operating Procedures in accordance with current Good Manufacturing Practices, focusing on right-first-time execution.
• Document activities in compliance with Good Documentation Practices in Batch Production Records, forms, and other quality documentation.
• Recognize deviations from intended procedures and raise awareness through the Rapid Response process; identify safety, quality, and efficiency improvements.
• Participate in the Catalent Way continuous improvement culture, lead “Just Do It” activities, and engage in continuous improvement projects.
• Coach junior team members on basic execution activities and act as an onboarding buddy for new hires.
• May become a Certified Trainer and take responsibility for final sign-off of training completion for basic execution activities.
• Interact with clients during Person In Plant or virtual observations to provide updates on batch schedule and status.
• Participate in daily shift huddles and lead shift exchange activities.
• Perform cleanroom housekeeping, including room and equipment cleaning, waste disposal, and maintenance of 5S standards.
• Perform other duties as assigned.
• Comply with Environmental Health and Safety responsibilities for the position.

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 eight 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