Senior Associate - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

The Biomanufacturing Sr. Associate position is an advanced level position in the Manufacturing team and is responsible for providing process and technical leadership during manufacturing of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures. Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

Requirements

Must have High School Diploma or equivalent plus at least seven (7) years of relevant experience.
Ability to use Microsoft Word and Excel, and other Office systems.

Nice To Haves

Bachelors or Associates Degree in a scientific, engineering, or biomanufacturing discipline with 3+ years of experience, or a Master’s in STEM with 1+ years of experience.
GMP manufacturing experience preferred.
Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software (i.e. Unicorn).

Responsibilities

Performs advanced troubleshooting and basic Downstream purification for mRNA production activities, such as in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing/qualification.
Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a "right-first-time" execution.
Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation.
Recognizes deviations from the intended procedure and raises awareness through the Rapid Response process.
Proactively identifies safety, quality, and efficiency improvements.
Actively participates in the Catalent Way (Continuous Improvement Culture).
Leads “Just Do It” (JDI) Continuous Improvement activities and engage in implementation of CI projects.
Acts as formal mentor for junior team members on basic execution activities and act as an “onboarding buddy” to bring new team members up to speed on culture and basic workplace expectations.
May become a Certified Trainer and take responsibility for the final sign-off of training completion for basic execution activities.
Interacts with clients during Person In Plant (PIP) or virtual PIP observations to provide updates on batch schedule and status.
Participates in daily shift huddles and leads shift exchange activities.
Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards.
Other duties as assigned.