Senior Manager, cGMP QC 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 Catalents 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 andcompliance 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:

• 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

Why you should join Catalent:

• 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 7000 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.

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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.