Technician - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions•Madison, WI

8d•Onsite

About The Position

This entry-level position is part of the Manufacturing team at Catalent’s Madison, Wisconsin facility. It is an initial opportunity to gain the skills and training needed to work in a cGMP biomanufacturing environment. The Technician manufactures biopharmaceutical products in a cleanroom, following detailed instructions and established procedures with frequent supervision. The facility supports biologics development and manufacturing using advanced mammalian cell line engineering and single-use systems. The work schedule is 2 p.m.–12 a.m., with availability for either a Sunday–Wednesday or Wednesday–Saturday shift. The position is 100% on-site in a heating, ventilation, and air-conditioned environment, and requires the ability to work in a cleanroom as needed.

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 may be accepted without formal experience.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to comply with environmental, health, and safety responsibilities.
Ability to work in a cleanroom environment.
Physical ability to frequently sit, stand, walk, read written documents, use a computer monitor, reach, talk, write, and listen; occasionally stoop, kneel, crouch, bend, carry, and grasp; frequently lift or move up to 10 pounds and occasionally lift or move 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 cGMPs, with a focus on right-first-time execution.
Document activities in BPRs, forms, and other quality records according to 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.
May lead Just Do It (JDI) continuous improvement activities and participate in implementing improvement projects.
May 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.