Technician - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions•Madison, WI

9d•Onsite

About The Position

This entry-level role is part of the Manufacturing team at Catalent’s Madison, Wisconsin facility. It provides a starting point for developing the skills and training needed in a cGMP biomanufacturing environment. The Technician manufactures biopharmaceutical products in a cleanroom, following detailed instructions and established procedures with frequent supervision. The role focuses on downstream purification and mRNA production activities. The facility is a 263,000-square-foot GMP site with mammalian cell line engineering and biomanufacturing capabilities using single-use systems, as well as integrated formulation and analytical services. This position is 100% on-site and works a 6 a.m.–4 p.m. schedule on either the Sunday–Wednesday or Wednesday–Saturday shift.

Requirements

High school diploma or equivalent and at least two years of relevant experience; alternatively, an associate or bachelor's degree in a scientific, engineering, or biomanufacturing discipline with no formal experience.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to work in a cleanroom environment and comply with the position's EHS responsibilities.
Meet the stated physical demands, 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.

Responsibilities

Perform basic downstream purification and mRNA production activities, including in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, and column packing and qualification.
Follow manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with cGMP requirements, emphasizing 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.
Identify safety, quality, and efficiency improvements and participate in the Catalent Way continuous improvement culture.
Potentially lead Just Do It (JDI) continuous improvement activities and participate in implementing improvement projects.
Potentially coach junior team members on basic execution activities and serve as an onboarding buddy.
Perform cleanroom housekeeping, including room and equipment cleaning, waste disposal, and maintaining 5S standards.
Perform other duties as assigned.