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Lead Associate - Biomanufacturing, Downstream - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 04/20/2024
Lead Associate - Biomanufacturing, DownstreamCatalent 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.----The Biomanufacturing Lead Associate position is a senior-level position in the Manufacturing team and is responsible for providing process and technical leadership during the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures.--This is a full-time salaried position, Monday - Friday, 8:00am to 5:00pmCatalent 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, bulk drug substance filling, and column packing/qualification
- Performs advanced troubleshooting during chromatography, TFF, viral filtration, IVT reactions, 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
- Leads "Just Do It" (JDI) Continuous Improvement activities and longer-term CI projects
- Acts as a formal "mentor" for more junior team members and coaches junior team members on complex production activities--
- Coordinates implementation of SOP and batch record updates, ensuring operator awareness and planning training where required
- Completes all training activities required to maintain quality compliance within expected milestones
- Other duties as assignedThe Candidate: --
- Requires Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 3 years of relevant experience OR--
- Bachelors or Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 5 years of relevant experience OR--
- High School Diploma with a minimum of 9 years of relevant experience
- Ability to operate within a clean room environment as needed
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 poundsWhy you should join Catalent:
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