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Director, Operations and MS&T - Princeton New Jersey
Company: Disability Solutions
Location: Princeton, New Jersey
Posted On: 11/16/2024
Job Title: Director MS&T and OperationsLocation: Princeton, NJPOSITION SUMMARYThe 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 collaborate 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 trend 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
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