Associate - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions • Madison, WI

1d • Onsite

About The Position

The Biomanufacturing Associate position is an intermediate-level position in the Manufacturing team and is responsible for the manufacturing of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures under supervision. 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 four (4) 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 1+ years of experience, or a Master’s in STEM without any formal experience.
• GMP manufacturing experience preferred.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software (i.e. Unicorn).

Responsibilities

• Performs basic troubleshooting and 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.
• May coach more 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.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED