Specialist I, MS&T

Specialist, Manufacturing Sciences & Technology

Summary:

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 in Kansas City, MO and Research Triangle Park, NC, 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.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.

The Manufacturing Sciences and Technology 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.

The Role:

• Provide technical training as necessary to operators, provide on-the-floor oversight of the manufacturing process, as necessary.
• Support the technical transfer processes by reviewing and understanding the prepared documents to be executed in the manufacturing areas.
• Utilize technical documentation (e.g., Master Batch Records, Equipment Drawings, Bill of Materials, Sampling Plans, Process Flow Diagrams, Process Descriptions) to derive technical information for project support.
• Provide client escort which entails interaction with client technical representatives, including Person in Plant observers on manufacturing floor.
• Perform technical troubleshooting as needed for manufacturing issues and assist operations to mitigate risk to the product being manufactured.
• Co-Ordinate and lead Rapid Response/Escalation calls.
• Collect initial information for Deviations, and complete any immediate actions identified and owned by MS&T team after the call.
• Generate a four block of the event and drive closure on all open action items owned by MS&T. Develop strong interdepartmental networks to enable prompt escalation response during a Rapid Response event.
• Coordinate/support responses to floor issues - Ensure escalation through proper channels and log all events into database.
• Enter all discrepancies/inaccuracies and required hand changes to batch records into Document Revision database prior to end of shift.
• Enter all floor observations into database, ensuring proper communication channels are followed for awareness.
• Mentor junior-level Specialists and Representatives, co-ops, and interns.

The Candidate:

• Bachelor's Degree in a Science or Engineering Field, required
• 3 - 5 years of relevant experience
• 3 years GMP or regulated industry experience, required
• Must be able to read and understand English-written job instructions and safety requirements

Position Benefits:

• 152 hours PTO & 8 Holidays
• Medical, Dental & Vision Benefits and 401k
• Tuition Reimbursement

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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