Upstream Manufacturing Group Lead (PM Shift)

Manufacturing Group Lead

Summary:

Catalent, 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.

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with GMP cleaning processes, solution preparation, master/working cell bank production, upstream cell culture and viral vector production, downstream purification, and fill/finish operations. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The Manufacturing Group Lead is a working lead responsible for daily execution of the operations schedule to deliver the desired output in a safe, compliant, and efficient manner.  The Group Lead has broad knowledge of manufacturing theories and principles, demonstrates systematic problem-solving skills, and integrates continuous improvement into the larger manufacturing organization guided by The Catalent Way. 

This is a full-time on-site position, 7pm-7am 2-2-3

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 daily production activities to ensure schedule adherence
• Coordinates, with indirect supervisory responsibilities, production activities for a group of Manufacturing Associates / Technicians
• Practices operational excellence methodologies in The Catalent Way and acts as a change agent for continuous improvement efforts
• Leads tier 1 meetings in the review and execution of people, safety, quality, delivery, and cost objectives
• Assists the supervisor with rapid response and problem resolution for daily issues
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
• Completes Batch Production Records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing steps
• May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP production
• Generate and revise internal and external documents (SOPs, BRs)
• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
• Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
• Recommend equipment and other supply purchases within the production areas
• Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
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