Director of Manufacturing Operations

6 days ago

Redwood City, California, United States Adicet Bio Inc. Full time
Job Summary

We are seeking a highly experienced and skilled Director of Manufacturing Operations to lead our viral vector and cell therapy production team at Adicet Bio Inc. This is a critical role that requires a strong background in biologics operations, with a focus on viral vector and cell therapy experience.

Key Responsibilities
  • Lead Production Team: Oversee the production team responsible for viral vector and cell therapy Current Good Manufacturing Practices (cGMP) and cGMP supply chain.
  • Ensure Timely Onboarding: Ensure timely onboarding of personnel to maximize training opportunities and to deliver all process and/or facility validation requirements.
  • Site Integration: Work with site teams to integrate with and influence established site systems as needed to implement new vector and cell therapy production operations.
  • Process Development: Create visibility to site integration activities and/or gaps and establish processes for site integration with production operations.
  • Tech Transfer: Lead all manufacturing aspects of tech transfer into manufacturing, including assessment of new product requirements against processes, generation of product-specific documentation, and supporting the introduction of new equipment, raw materials, and/or consumables.
  • Process Qualification: Lead qualification of processes as needed for production and to ensure readiness for product introduction.
  • Manufacturing Area Plan: Develop manufacturing area plan and systems/processes that support both the project and operationalizing the manufacturing facility.
  • Manufacturing Activities: Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
  • Supply Chain Management: Adhere to clinical and launch supply chain targets by meeting or exceeding monthly and annual production output demand.
  • Safety Culture: Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives.
  • Cost Center Management: Be responsible for department cost center by reviewing monthly costs.
  • Production Output and Operating Budgets: Prepare and adhere to production output and operating budgets for department.
  • Compliance and Continuous Improvement: Continuously seek opportunities for improving overall compliance and reduce discrepancies.
  • Quality Partnership: Partner with Quality to implement and manage phase-appropriate systems/processes/procedures to meet cGMP manufacturing requirements against regulatory standards in various regions (US/EU/etc.).
  • Adverse Trend Management: Track adverse trends and ensure they are addressed quickly and effectively.
  • Deviation and Non-Conformance Management: Provide direction and/or act as escalation point for unresolved deviations/non-conformances.
  • CAPAs: Partner with Quality and Engineering representatives to implement effective corrective and preventative actions (CAPAs) to mitigate reoccurrence.
Qualifications
  • Education and Experience: Bachelor of Science and at least 10 years of experience or Master of Science and at least eight years of experience or Ph.D. and at least six years of experience.
  • Manufacturing Experience: Manufacturing experience in biologics operations required, with viral vector and cell therapy experience much preferred.
  • Manufacturing Aspects: Highly familiar with all of the following manufacturing aspects: aseptic processing, expansion and differentiation of CAR-T products (allogenic and/or autologous), generation of viral vectors in adherent cultures, and formulation of cellular therapeutics.
  • Regulatory Knowledge: Understanding of cGMP Directives, industry guidelines, and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
  • Leadership Skills: Strong leadership skills, ability to communicate and partner well with all levels of staff, to lead and motivate with emphasis on compliance and continuous improvement, and to resolve conflicts.
  • Process Control: Ability to monitor and control processes using data trending and/or statistical process control.
  • Troubleshooting: Proven ability to troubleshoot and resolve issues.
  • Communication: Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams.

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