Associate Biomanufacturing, DownstreammRNA

Associate - Biomanufacturing Downstream/mRNA

Position Summary:

• Work Schedule: 6am-4pm (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 263000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

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.

The Role:

• 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 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.
• 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.

The Candidate:

• Must have High School Diploma or equivalent plus at least four (4) years of relevant experience. We will also accept a Bachelors or Associates Degree in a scientific engineering or biomanufacturing discipline with 1 years of experience or a Masters in STEM without any formal 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 7000 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.