Associate Director/ Director, Process Development

Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our growing cell and gene therapy development team in San Diego, CA.  The incumbant will be responsible for evaluating early product candidates through initial process development and process transfer to Poseida’s cell therapy development team and/or CMO. The incumbant will be involved with developing Poseida’s platform cell and gene therapy production processes and ensuring processes mature to meet requirements for the specific  stage of product development.

Key Responsibilities:

  • Responsible for developing phase-appropriate cell and gene therapy production processes using QBD principles and aid in the transferring of process to late process development and/or CMO for early phase GMP clinical manufacturing
  • Responsible for process improvement initiatives to streamline manufacturing, or improve process robustness or cost of goods
  • Assist in development of product-specific analytical methods to characterize and/or for release of cell therapy products
  • Contribute to regulatory filings as requested by the head of Cell and Gene Therapy Development or Regulatory
  • Provide creative solutions to mitigate CMC issues to achieve company goals and objective.
  • Provide effective leadership to build and coach the early PD team to ensure continued development and growth
  • Responsible for effective leadership and participation in high impact cross functional initiatives

Required Experience and Skills:

  • PhD in immunology or related discipline with ≥ 7+ years post-graduate work experience. .
  • Experience developing gene therapy, CAR-T, or hematopoetic stem cell production processes.
  • ≥3 yrs experience with GMP manufacturing of cell and gene therapy or biological products is desired. The ideal candidate will also have experience with working with contract manufacturing organizations, vendors and partners.
  • Experience with developing analytical methods, such as qPCR, FACS, ELISA, and RNA expression to support process development.
  • The ideal candidate will have experience with managing and leading direct reports
  • Excellent leadership and communication skills in cross-functional environments
  • Problem solving capabilities with focus on creativity in problem identification and resolution and a relentless, hands-on drive to implement and accomplish company goals and objectives in a rapid-paced, changing business environment.
  • Results oriented, resourceful individual with a highly entrepreneurial style and ability to achieve results in a fast-paced rapidly changing environment without the infrastructure found in large companies
  • Stay current with process technology trends and best practices for cell and gene therapy process development and GMP manufacturing
  • Ability to use JMP, MiniTAb, or other statistical software for assessing unit process quality parameters
  • Strong presence, focus and drive to succeed—confidence, passion, and high energy.
  • Ability to work in a fast-moving dynamic small company environment.
  • Ability to travel up to 20% of time
  • Outstanding written and oral communication skills are essential; report, IND, SOP, batch record, and work instructions
  • Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management and partners
  • High sense of integrity and professionalism and the ability to work well in a cross functional team environment