Supervisor, Central Services

Supervisor, Central Services

(Night Shift)

Catalent Pharma Solutions is looking to hire a Supervisor, Central Services (Night Shift) to support our Gene Therapy Team in Harmans, MD

This position will take place on night shift, (7:00pm-7:00am on a 2-3-2 rotation). This role will require a rotating schedule that will include working on Weekends.

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.

The Central Services (CS) department is responsible for the execution of clinical and commercial standard manufacturing process (SMP). The buffers and media prepped by CS are used for 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 Supervisor, Central Services is responsible for supporting the overall cGMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk products from microbial and cell culture systems for Phase I/II GMP manufacturing.

The Supervisor, Central Services performs production operations including but not limited to preparation of media and buffer solutions as well as being involved in both start-up and product changeover activities, and completing daily manufacturing tasks as well as supporting more in-depth, long term projects.

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

• Completes daily manufacturing tasks per standard operating procedures and batch document instructions and monitors critical process parameters.
• During technical transfer and the start-up activities, provide input on design and operation of equipment and effectively troubleshoot equipment and processing problems.
• Lead resolution of technical and process problems, initiate change control for equipment/process modifications.
• Demonstrates daily focus on safe behaviors and adept at recognizing unsafe conditions.
• Thorough understanding of quality systems in regulated environment and fully committed to right first time (RFT)
• Identify, develop and implement process improvements, equipment improvements/upgrades.
• Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
• Receive, stage and track materials.
• Ensures all production activities are completed in a safe and compliant manor.
• Communicate assignments, milestones and deadlines to the team and individuals based on supervisor's instructions.
• Monitor and audit work processes to ensure compliance and completion of targets.
• Trains new and less experienced team members.
• Other duties as assigned

The Candidate