Senior Associate - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions•Madison, WI

8d•Onsite

About The Position

The Senior Associate - Biomanufacturing, Downstream/mRNA is an advanced-level member of the Manufacturing team, providing process and technical leadership during biopharmaceutical manufacturing in a cleanroom environment. The role performs advanced troubleshooting and basic downstream purification activities for mRNA production, while following detailed instructions and established procedures. Work is 100% on-site in Madison, Wisconsin, with an evening schedule of 2 p.m. to midnight, working either Sunday–Wednesday or Wednesday–Saturday. The position requires accurate execution of manufacturing batch records and standard operating procedures in accordance with current Good Manufacturing Practices, and documentation in accordance with Good Documentation Practices. The Senior Associate supports safety, quality, efficiency, and continuous improvement; mentors and helps onboard junior team members; and may become a certified trainer. The role also interacts with clients during in-person or virtual observations, participates in shift huddles and handoffs, and performs cleanroom housekeeping.

Requirements

High school diploma or equivalent and at least seven years of relevant experience; alternatively, an associate or bachelor's degree in a scientific, engineering, or biomanufacturing discipline and at least three years of experience; or a master's degree in STEM and at least one year of experience.
Ability to use Microsoft Word, Excel, and other Office systems.
Comply with EHS responsibilities for the position.
Ability to work in a cleanroom environment as needed.
Physical ability to frequently sit, stand, walk, read written documents, use a computer monitor, reach with hands and arms, 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, and chromatography software such as Unicorn.

Responsibilities

Perform advanced troubleshooting and basic 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, with a focus on right-first-time execution.
Document activities in Batch Production Records, 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 activities, and engage in continuous improvement project implementation.
Mentor junior team members on basic execution activities and act as an onboarding buddy for new team members.
May become a Certified Trainer and provide final sign-off for training completion in basic execution activities.
Interact with clients during in-person or virtual Person In Plant observations and provide updates on batch schedule and status.
Participate in daily shift huddles and lead shift exchange activities.
Perform cleanroom housekeeping, including cleaning rooms and equipment, disposing of waste, and maintaining 5S standards.
Perform other duties as assigned.