Director of Manufacturing and Technology

1 week ago

Princeton, New Jersey, United States Catalent Inc Full time
Job Title: Director of Manufacturing and Technology

Location: Princeton, NJ

Position Summary

The Director of Manufacturing and Technology is responsible for leading teams while overseeing the GMP manufacturing and MS&T processes, utilizing a broad knowledge of theories and principles to solve operational and routine tasks in the production of cell therapy products.

Key Responsibilities
  • Strategic client-facing leader of the MS&T team on 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.
  • Leads the evaluation, remediation, and optimization of products and processes using statistical tools to ensure safety, quality, delivery, and cost standards.
  • Enhances productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for manufacturing processes.
  • Ensures 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.
  • Bridges the focus areas of P&D, Quality, EHS, Production, Supply Chain, and Engineering to create a 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 improvements to improve efficiency, consistency, and competitiveness within the market.
  • Provides business cases 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.
  • Leads in addressing deficiencies and ensures 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 improving 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.

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