Technician - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions•Madison, WI

8d•Onsite

About The Position

Catalent is hiring an entry-level Technician for its Manufacturing team at its 263,000-square-foot GMP facility in Madison, Wisconsin. The facility provides mammalian cell line engineering and biomanufacturing capabilities using single-use systems, along with formulation and analytical services. The Technician manufactures biopharmaceutical products in a cleanroom, follows detailed instructions and established procedures, and works under frequent supervision. The position is fully on-site and has an overnight schedule of 10 p.m. to 8 a.m., with availability for either the Sunday–Wednesday or Wednesday–Saturday shift. A $5,000 sign-on bonus is offered. The role provides a starting point for developing skills and receiving training for work in a cGMP biomanufacturing environment. Activities include downstream purification and mRNA production, such as in-vitro transcription reactions, chromatography, tangential flow filtration, viral filtration, and column packing and qualification. The Technician follows batch records and procedures, documents work, reports deviations, contributes to continuous improvement, and maintains cleanroom housekeeping and 5S standards. The physical work environment is heating, ventilation, and air-conditioning controlled, and the employee must be able to work in a cleanroom as needed. The role involves frequent sitting, standing, walking, reading, computer use, reaching, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping; frequent lifting or moving of up to 10 pounds; and occasional lifting or moving of up to 50 pounds. The employee must comply with the position’s EHS responsibilities.

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 is accepted without formal experience.
Ability to use Microsoft Word, Excel, and other Office systems.
Ability to work in a cleanroom environment as needed and comply with EHS responsibilities.
Meet the stated physical requirements, 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 reactions, chromatography, tangential flow filtration, viral filtration, 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.
Identify safety, quality, and efficiency improvements and participate in the Catalent Way continuous improvement culture.
May lead Just Do It continuous improvement activities and participate in implementing continuous improvement projects.
May coach more junior team members on basic execution and serve as an onboarding buddy for new team members.
Perform cleanroom housekeeping, including cleaning rooms and equipment, disposing of waste, and maintaining 5S standards.
Perform other duties as assigned.