Senior Manager, cGMP QC Laboratory

Catalent•Morrisville, NC

10d

About The Position

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.

Requirements

Ph.D., M.S., or B.S. in Chemistry, Pharmaceutical Sciences or Life Sciences.
Minimum of 5 years of management experience in the pharmaceutical industry.
Minimum of 10 years of Chemistry laboratory experience with HPLC/GC/UV, etc.
Must be able to interact with other departments within Catalent on daily basis and make extensive independent judgments
Strong leadership skills, driving accountability, compliance and efficiency
Extensive technical experience in analytical techniques and troubleshooting skills in HPLC/GC/UV/IR/Dissolution etc.
Significant quality control experience handing OOS/OOT investigations with statistical analysis and risk assessment
Solid knowledge of cGMP, ICH, FDA, EMA regulations or guidelines

Responsibilities

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.

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 Hours + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Company match on donations to organizations
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or start a new degree!
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.