Senior Associate - Biomanufacturing, Downstream/mRNA

Catalent • Madison, WI

4h • Onsite

About The Position

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO) located in Madison, WI. This facility specializes in advanced mammalian cell line engineering and biomanufacturing using single-use systems for scalable production. The 263,000 sq. ft. GMP facility integrates formulation and analytical services for complex Biologics development challenges. The Biomanufacturing Sr. Associate is an advanced role within the Manufacturing team, providing process and technical leadership for biopharmaceutical product manufacturing in a cleanroom environment, adhering strictly to detailed instructions and established procedures.

Requirements

• High School Diploma or equivalent plus at least seven (7) years of relevant experience.
• Bachelors or Associates Degree in a scientific, engineering, or biomanufacturing discipline with 3+ years of experience.
• Master’s in STEM with 1+ years of experience.
• Ability to use Microsoft Word and Excel, and other Office systems.

Nice To Haves

• 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 focus on “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.

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

What This Job Offers

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