Senior Associate - Biomanufacturing, Downstream/mRNA

Senior Associate - Biomanufacturing, Downstream/mRNA

Position Summary:

Work Schedule: 2pm-12am (Sunday-Wednesday or WednesdaySaturday shift availability)

100% on-site

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.

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.

The Role:

• 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.

The Candidate:

• Must have High School Diploma or equivalent plus at least seven (7) years of relevant experience. We will also accept a 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.
• Ability to use Microsoft Word and Excel, and other Office systems.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, and Chromatography software (i.e. Unicorn).
• Physical requirements: This position requires frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Why you should join Catalent:

• 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!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.