Associate - Biomanufacturing, Downstream/mRNA

Catalent•Madison, WI

21d•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 basic troubleshooting and downstream purification activities for mRNA production. This is a 100% onsite role at Catalent’s GMP biomanufacturing facility in Madison, Wisconsin, with a 2 p.m.–12 a.m. schedule available Sunday–Wednesday or Wednesday–Saturday. The position supports safe, compliant manufacturing through accurate execution of batch records and procedures, thorough documentation, and prompt escalation of deviations. It also contributes to continuous improvement, team training and onboarding, client updates, shift communication, and cleanroom housekeeping. The facility is a 263,000-square-foot GMP site with mammalian cell line engineering, single-use biomanufacturing, formulation, and analytical capabilities.

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 and at least one year of experience; or a master’s degree in a STEM field with no formal experience required.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to work in a cleanroom environment as needed and comply with position-specific EHS responsibilities.
Ability to perform the stated physical activities, including frequent lifting or moving of up to 10 pounds and occasional lifting or moving of up to 50 pounds.

Nice To Haves

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

Responsibilities

Perform basic troubleshooting and downstream purification for mRNA production, including in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing and qualification.
Follow Manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs), with a focus on right-first-time execution.
Document activities in BPRs, forms, and other quality documentation in accordance with Good Documentation Practices (GDPs).
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 (JDI) activities, and engage in continuous improvement projects.
Coach more junior team members on basic execution activities and potentially act as an onboarding buddy for new team members.
Potentially become a Certified Trainer and sign off on training completion for basic execution activities.
Interact with clients during in-person or virtual Person In Plant (PIP) observations, providing updates on batch schedules and status.
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.