DIRECTOR OF MANUFACTURING, VIRAL VECTOR AND CELL THERAPY
Responsibilities:
- Lead production team for viral vector and cell therapy Current Good Manufacturing Practices manufacturing (cGMP) and cGMP supply chain.
- Ensure timely onboarding of personnel to maximize training opportunities and to deliver all process and/or facility validation requirements.
- Work with site teams to integrate with and influence established site systems as needed to implement new vector and cell therapy production operations.
- Create visibility to site integration activities and/or gaps and establish processes for site integration with production operations (or vice versa).
- Lead all manufacturing aspects of tech transfer into manufacturing including, but not limited to, assessment of new product requirements against processes, generation of product specific documentation, supporting the introduction of new equipment, raw materials and/or consumables, determine safety implications if any and training of personnel.
- Lead qualification of processes as needed for production and to ensure readiness for product introduction.
- Develop manufacturing area plan and systems/processes that support both the project and operationalizing the manufacturing facility.
- 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.
- Adhere to clinical and launch supply chain targets by meeting or exceeding monthly and annual production output demand.
- Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives.
- Be responsible for department cost center by reviewing monthly costs.
- Prepare and adhere to production output and operating budgets for department.
- Continuously seek opportunities for improving overall compliance and reduce discrepancies.
- 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.)
- Track adverse trends and ensure they are addressed quickly and effectively.
- Provide direction and/or act as escalation point for unresolved deviations/non conformances.
- Partner with Quality and Engineering representatives to implement effective corrective and preventative actions (CAPAs) to mitigate reoccurrence.
Qualifications:
- 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 in biologics operations required, with viral vector and cell therapy experience much preferred.
- 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.
- Understanding of cGMP Directives, industry guidelines and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
- 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.
- Ability to monitor and control processes using data trending and/or statistical process control.
- Proven ability to troubleshoot and resolve issues.
- Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams.
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