Senior Manager, cGMP QC Laboratory

Senior Manager, Quality Control Laboratory

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.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI, and Nasal Sprays.

Catalent Pharma Solutions in Morrisville, NC is hiring a Senior Manager, Quality Control Laboratory. The Senior Manager, Quality Control Laboratory is responsible for overseeing the commercial operation activities within the Quality Control department including raw material, in-process sample, stability, and finished product release to meet cGMP regulations and project timelines. They are also responsible for overseeing supplier assurance, QC document change controls, LIR / Deviations, and raw material sampling.

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 :

• Oversee daily aspects of QC laboratory including but not limited to testing and release of raw materials, in-process samples, finished products, cleaning verification samples, stability testing and protocol testing sample, etc.
• Attain strategic plans, establish goals and objectives, supervise work practice, interpret and execute policies and procedures that typically affect organizational unit.
• Manages the resources and capacity to ensure QC has proper staffing and equipment to support commercial and clinical products production for both near and long term.
• Provides technical and compliance guidance to the QC laboratory with strong analytical techniques and troubleshooting skills in HPLC / GC / UV / IR / Dissolution, etc.
• Prepares the Quality Control lab for regulatory and customer inspections.
• Interacts with customers from an analytical standpoint to support on-going and future initiatives.
• Oversee QC laboratory documents control for test methods, specifications, training records, notebooks, logbooks, etc.

The Candidate :

Why you should join Catalent :

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.

Personal initiative. Dynamic pace. Meaningful work.