Associate - Biomanufacturing, Upstream
About The Position
Catalent’s Madison, Wisconsin site is a biologics development and manufacturing facility supporting research through early- and mid-stage clinical production. The site specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, using flexible single-use systems and supporting clinical manufacturing scales from 50 to 4,000 liters. The Associate - Biomanufacturing, Upstream performs upstream cell culture activities and basic troubleshooting in a controlled environment. The role follows established procedures and documentation standards to ensure compliance and quality, and contributes to continuous improvement and production of biologic therapies. The position is 100% onsite in Madison, Wisconsin, working either Sunday through Wednesday or Wednesday through Saturday, from 6 a.m. to 4 p.m.
Requirements
- High school diploma or equivalent plus at least four years of relevant experience; or a Bachelor’s or Associate degree in a scientific, engineering, or biomanufacturing discipline plus one or more years of experience; or a Master’s in Science, Technology, Engineering, or Mathematics with no formal experience required.
- Ability to use Microsoft Word, Excel, and other Office systems.
- Ability to perform frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching with hands and arms, 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.
- Must comply with Environmental Health and Safety responsibilities for the position.
- Ability to operate within a clean room environment as needed.
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.
Benefits
- Competitive paid time off
- Eight paid holidays
- Medical benefits effective day one of employment
- Dental benefits effective day one of employment
- Vision benefits effective day one of employment
- Tuition reimbursement
- Defined career path and annual performance review and feedback process
- Potential for career growth
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
