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Technician - Biomanufacturing, Downstream/mRNA - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 04/18/2024
Technician - Biomanufacturing, Downstream/mRNACatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.--The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.-- Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.--This position is an entry level position in the Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.--This is a full-time on-site hourly position, Sunday - Wednesday 6:00am to 4:00pm.Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role: -- - Performs basic Downstream purification and mRNA production activities, such as in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, and column packing and 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)
- May lead "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 facilitate bringing new team members quickly up to speed on culture and basic workplace expectations
- Participates in daily shift huddles and may lead shift exchange activities
- Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards
- Other duties as assignedThe Candidate: --
- Requires Bachelors or Associates Degree in a scientific, engineering or biomanufacturing discipline with no experience required OR
- High School Diploma with a minimum of 2 years of relevant experience
- GMP experience preferred
- Individual may be required to lift and/or move 0-10 pounds frequently, and occasionally moving and/or lifting up to 50 poundsWhy you should join Catalent:
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