Director, Operations and MS&T

Job Title: Director MS&T and Operations

Location: Princeton, NJ

POSITION SUMMARY

The Director of MS&T and Operations is responsible for leading teams while overseeing the GMP manufacturing, and MS&T processes, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapy products. The incumbent is also responsible for managing day-to-day operations of the department to ensure timely delivery of client-sponsored projects by providing strong technical leadership and collaborating effectively across groups within the organization.

KEY RESPONSIBILITIES

Strategic client facing leader of the MS&T team on the behalf of the organization.

Leads a team of engineers and scientists responsible for the effective technology transfer of processes into Manufacturing for both internally and externally developed processes.

Works cross-functionally with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility.

Participates and leads commercial manufacturing transition and support for process development.

Supports process characterization and validation in preparation for commercialization.

Lead the evaluation, remediation and optimization of products and processes using statistical tools to ensure safety, quality, delivery and cost standards.

Enhance productivity by exploring, analyzing, facilitating and leveraging efficiency initiatives for manufacturing processes.

Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.

Bridge the focus areas of P&D, Quality, EHS, Production, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless manufacturing.

Works closely with manufacturing to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements.

Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.

Collects and trends process data for external (Clients) and internal review to ensure process consistency.

Evaluates existing processes and identifies process and/or equipment improvement to improve efficiency, consistency, and competitiveness within the market. This includes development of project requirements, feasibility, and technical design for implementation into cGMP environment.

Provides business case for process improvement projects.

Authors and reviews technical reports, process tech transfer summary reports, master batch records, product and equipment specifications, and protocols in support of tech transfer and cGMP activities.

Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification.

Responsible for maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff.

Oversight of cell therapy production operations including a thorough understanding of producing autologous and allogeneic products.

Leads coordination and integration efforts among operations, engineering, technology, and program management divisions to produce smoother workflow and more cost-effective business processes.

Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive client and internal stakeholder communication.

Will oversee and ensure compliance when creating, revising, and editing procedures and specs as needed.

Lead in addressing deficiencies and ensure completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all operational issues according to GMP standards and company objectives.

Leads development and maintains metrics to track operations and training record turnaround time, errors, and document related deviations.

Leads by example, keeping in mind organizational values, policies, and goals.

Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding and OJT is a positive experience.

Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on cross-training and continuously improves production records.

Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives.

POSITION REQUIREMENTS

B.S. in Engineering or Science discipline and 10+ years of GMP cell therapy and/or biologics/gene therapy manufacturing experience OR M.S. in Engineering in a Science discipline plus 10+ years of GMP cell therapy and/or biologics/gene therapy manufacturing experience.

Manufacturing experience includes autologous and/or allogeneic manufacture, extensive experience with cell therapy equipment, aseptic manufacture procedures and supply chain process and material controls.

Must have experience in a CDMO or CMO environment.

Minimum of 6 years of leadership experience required.

Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.

Ability to effectively present information and respond to questions from peers, management, suppliers and customers.

Ability to work effectively under pressure to meet deadlines.

Be accessible to manufacturing floor and office staff and to use required office equipment.

Specific vision requirements include reading of written documents and frequent use of computer monitor.

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

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 within an organization dedicated to preserving and bettering lives.

Dynamic, fast-paced work environment.

Community engagement and green initiatives.

Generous 401K match and Paid Time Off accrual.

Medical, dental and vision 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.

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