Manager, Quality Control

Manager, Quality Control Position Summary:

Work Schedule:

Monday - Friday, 8:00am-5:00pm. 100% on-site Catalent is a leading global CDMO, trusted by pharma, biotech and self-care companies to accelerate the development, manufacturing and delivery of products that improve lives. With advanced technologies, deep expertise and a worldwide network, we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions. Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent's cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The Manager, Quality Control is responsible for organizing and supervising daily Quality Control activities to ensure testing schedules are executed as planned. This role partners closely with Quality Assurance to maintain a compliant quality environment, including supporting investigations, documentation, audit readiness, and informing QA of any quality issues arising from analytical or microbiology testing. The Manager maintains close communication with Manufacturing and Supply to support on-time delivery of drug product and collaborates with Facilities to report instrument issues and coordinate repairs, calibrations, and other required instrument interventions. The Manager, Quality Control, reports to the Director, Quality and is responsible for leading and managing a team of Quality Control Scientists.

The Role:

Coordinate the QC lab activities to meet production goals, quality and cost objectives. Provide support to analyst in troubleshooting QC testing methods and instruments. Supervise daily QC activities and ensure schedule is followed. Perform analytical, microbiological and raw material dossier review. Review all QC forms and logbooks used for daily operations. Assist in OOS investigations. Assist in instrument qualifications. Lead training of QC analyst. Execute Method Validation, IPC, CFP, Microbiological and Raw Material Test. Author and revise QC lab documents such as SOP, Specifications, Protocols and Reports. Set and ensure a regular follow up of the individual SMART objectives in collaboration with the members of his/her team. Implement/ Execute the company strategy and organizes the activities within his/her team. Measure the performance of his/her team. Share relevant information and communicates with his/her team. Develop each team member's autonomy and expertise, through training and any other development opportunity mainly. Other duties are assigned.

The Candidate:

Bachelor in a Life Sciences discipline with a minimum of 8 years of experience working in a cGMP QC laboratory OR Masters' in a Life Sciences discipline with a minimum of 6 years of experience working in a cGMP QC laboratory. 2 - 4 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as

NGGL, GOLD, LEAD

Now, GM Excellence, and GROW) may be considered in place of external experience. Skilled in Instrument qualification, method Validation, Aseptic technique, and cGMP compliant lab experience. Strong Writing, Excel, Word and Power point skills. Excellent understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP requirement and SOP's. Ability to foster a culture of continuous improvement and excellence in the QC laboratory area Outstanding leadership and management capabilities to build, motivate and manage a team. Good problem solving and organizational skills. Strong written and verbal communication skills in English, with the ability to work cross‑functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test). The anticipated salary range for this position in New Jersey is $130,000 - $160,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should

Join Catalent:

Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth on an expanding team. Cross-functional exposure to other areas within the organization. 152 hours of paid time off annually + 8 paid holidays. Medical, dental, vision and 401K benefits effective day one of employment. Tuition Reimbursement. 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. 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE. 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.