Director of Operations and MS&T

2 days ago

Princeton, New Jersey, United States Catalent Inc Full time
Job Title:

Director of Operations and MS&T

Job Summary:

The Director of Operations and MS&T is responsible for leading teams and overseeing the GMP manufacturing and MS&T processes. This role requires 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
  • Leads a team of engineers and scientists responsible for technology transfer of processes into manufacturing
  • Works cross-functionally with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments
  • Participates in 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
  • Enhances productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for manufacturing processes
  • Ensures 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
  • Works closely with manufacturing to provide on-the-floor technical oversight
  • Leads the compilation of process data and delivers internal and client presentations
  • Collects and trends process data for external and internal review
  • Evaluates existing processes and identifies process and/or equipment improvement opportunities
  • 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
  • Acts as the lead for technical support deviations, change controls, and CAPAs
  • 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
  • Works closely with production staff to troubleshoot process and equipment problems
  • Ensures compliance when creating, revising, and editing procedures and specs
  • Leads in addressing deficiencies and ensures completion of all follow-up actions
  • 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
  • Ensures the proper processes are in place for GMP and Safety training of staff
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
Why 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

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