Associate - Biomanufacturing, Downstream/mRNA

Catalent•Madison, WI

5d•Onsite

About The Position

The Biomanufacturing Associate is an intermediate-level member of the Manufacturing team responsible for manufacturing biopharmaceutical products in a cleanroom environment. The role follows detailed instructions and established procedures under supervision and performs downstream purification activities for mRNA production. The position is 100% on-site, with a 10 p.m.–8 a.m. schedule available Sunday–Wednesday or Wednesday–Saturday. A $5,000 sign-on bonus is offered. Catalent’s Madison, Wisconsin facility is a 263,000-square-foot GMP site with mammalian cell line engineering and biomanufacturing capabilities using single-use systems, along with integrated formulation and analytical services. The Associate performs manufacturing and documentation activities in accordance with cGMP, GDP, Batch Production Records, and Standard Operating Procedures. The role also includes cleanroom housekeeping, continuous improvement participation, shift communication, and possible coaching or training of team members. The position requires compliance with EHS responsibilities and the ability to work in a controlled, cleanroom environment.

Requirements

High school diploma or equivalent and at least four years of relevant experience; alternatively, an associate or bachelor's degree in a scientific, engineering, or biomanufacturing discipline with at least one year of experience; or a master's degree in STEM with no formal experience required.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to meet the physical requirements of the position, 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 cleanroom environment as needed.
Must comply with EHS responsibilities for the position.

Nice To Haves

GMP manufacturing experience.
Experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and chromatography software such as Unicorn.

Responsibilities

Perform basic troubleshooting and downstream purification for mRNA production, including in-vitro transcription reactions, chromatography, tangential flow filtration, viral filtration, bulk drug substance filling, and column packing and qualification.
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 BPRs, forms, and other quality documentation in accordance with Good Documentation Practices.
Recognize deviations from intended procedures and raise awareness through the Rapid Response process.
Proactively identify safety, quality, and efficiency improvements.
Participate in the Catalent Way continuous improvement culture, lead Just Do It continuous improvement activities, and engage in implementation of continuous improvement projects.
Coach more junior team members on basic execution activities and potentially act as an onboarding buddy.
Potentially become a Certified Trainer and provide final sign-off for training completion on basic execution activities.
Interact with clients during in-person or virtual Person In Plant observations, providing batch schedule and status updates.
Participate in daily shift huddles and lead shift exchange activities.
Perform cleanroom housekeeping, including room and equipment cleaning, waste disposal, and maintaining 5S standards.
Perform other duties as assigned.