Summary

Catalent Cell & Gene Therapy is looking to recruit a Sr. Manager, Quality Control to join our growing team in Princeton, NJ.

The Sr. Manager, Quality Control - Bioanalytical is accountable for leading all bioanalytical methods in support of clinical and commercial cell therapy operations for our Princeton, NJ site.

This candidate must demonstrate expert knowledge, skills, and abilities as it relates to Quality Control for Cell Therapy products with advanced hands-on experience with various analytical techniques including but not limited to: ELISA, qPCR, Flow Cytometry and scientific knowledge in the cell therapy product release field.

Catalent is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent Cell and Gene Therapy provides process development, process characterization, and GMP manufacturing services to industry leaders utilizing novel technologies to produce state-of-the-art vaccines and gene therapies. As a Catalent employee, you will actively contribute to the delivery of services to our clients and impact the well-being of their patients.

The Role:

• Manage the day-to-day operations in the assigned area of the QC Bioanalytical department.
• Ensure staff are fully trained on all cGMP manufacturing operations, documentation and adhering to safety guidelines
• Build effective teams that apply their diverse skills and perspectives to achieve common goals.
• Oversee and provide strong guidance for the performance of assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, Flow Cytometry, and Cell Culture.
• Strong expertise in generating internal and external documents such as assay protocols, summary reports, and SOPs
• Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns
• Prepare for and participate in audits and inspections.
• Reviews laboratory work and approves data packages as designated by the Supervisor
• Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
• Other duties as assigned

The Candidate

• Bachelor’s degree in Biology, Biochemistry, Chemistry or Bioengineering or Life Sciences with relevant experience in the fields of Biotech/Pharma/Cell Therapy. Advanced Degree (MS) Preferred.
• At least 10 years’ experience in a current Good Manufacturing Practice (cGMP) biopharmaceutical environment, including 4-6 years of people management.
• Minimum 5 years’ experience in QC of a pharmaceutical company.
• Team leader and excellent communicator, quality minded and customer oriented.
• Experience in QC equipment qualification.
• Experience in analytical methods validation and statistics.
• Experience in cell therapy or quality control of cells from human tissue origin preferred.

Position Benefits

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• Employee Stock Purchase Plan
• 19 days PTO and 8 paid holidays

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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:

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