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 role on Catalent’s Manufacturing team, providing process and technical leadership during biopharmaceutical manufacturing in a cleanroom environment. The role follows detailed instructions and established procedures while performing 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. The position is 100% on-site at Catalent’s GMP biomanufacturing facility in Madison, Wisconsin. The schedule is 10 p.m.–8 a.m., with Sunday–Wednesday or Wednesday–Saturday shift availability. The role requires accurate execution and documentation of manufacturing activities under applicable GMP and documentation practices, attention to safety and quality, and participation in continuous improvement. The Senior Associate also mentors and trains junior team members, supports client observations, and contributes to shift coordination and cleanroom housekeeping.

Requirements

High school diploma or equivalent plus at least 7 years of relevant experience; alternatively, an associate or bachelor's degree in a scientific, engineering, or biomanufacturing discipline with 3 or more years of experience, or a master's degree in STEM with 1 or more years of experience.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to operate in a cleanroom environment as needed.
Must comply with the position’s EHS responsibilities.
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, emphasizing 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 implementation of continuous improvement projects.
Formally mentor junior team members on basic execution activities and serve as an onboarding buddy for new team members.
May become a Certified Trainer and take responsibility for final sign-off of training completion for basic execution activities.
Interact with clients during in-person or virtual Person In Plant observations, providing updates on batch schedule and status.
Participate in daily shift huddles and lead shift exchange activities.
Perform cleanroom housekeeping, including room and equipment cleaning, waste disposal, and maintenance of 5S standards.
Perform other duties as assigned.