Lead Associate - Biomanufacturing, Upstream

Company: Disability Solutions
Location: Madison
Posted on: February 1, 2025

Job Description:

Lead Associate - Biomanufacturing, UpstreamCatalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.--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 Upstream cell culture activities, such as aseptic manipulation of cell culture within a Grade A environment, large-scale cell culture within single-use bioreactors (SUBs), clarification of bulk harvest product, and cell bank vialing
• Performs advanced troubleshooting during aseptic processing, large-scale cell culture activities, clarification of bulk harvest product, and cell bank filling operations
• 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
  • Individual may be required to lift and/or move 0-10 pounds frequently, and occasionally moving and/or lifting up to 50 pounds
  • 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 is required
  • Must comply with EHS responsibilities for the positionWhy 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 paid time off annually +--8--paid holidays--
    • Competitive salary with yearly bonus potential--
    • Community engagement and green initiatives--
    • Generous 401K match and Paid Time Off accrual--
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition ReimbursementCatalent 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.Visit 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

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