Process Development Scientist
Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our growing cell therapy development team at San Diego, CA. The Process Development Scientist will be responsible for directing product candidates through process development and support process transfer to Poseida’s cell therapy CMO. This position will be involved with developing Poseida’s platform cell therapy production processes and ensuring processes mature to meet requirements for the specific stage of product development. The Process Development Scientist is expected to keep current with process technology trends and best practices for cell therapy process development and GMP manufacturing. Primarily, the role will:
- Responsible for developing phase-appropriate cell therapy production processes using QBD principles and aid in the transferring of process to CMO for early phase GMP clinical manufacturing
- Develop platform production processes and ensure processes are suitable for late-stage GMP clinical development and commercial production
- 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 Therapy Development or Regulatory
- Provide creative solutions to mitigate CMC issues to achieve company goals and objective.
- Provide effective leadership and coaching to the team to ensure 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 3+ years post-graduate work experience. .
- Experience developing CAR-T or hematopoetic stem cell production processes.
- 2-3 yrs experience with GMP manufacturing of cell therapy or biological products is desired. The ideal candidate will also have experience with working with contract manufacturing organizations, vendors and partners.
- Experience with analytical methods, such as qPCR, FACS, ELISA, and RNA expression.
- 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
- 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, SOP, batch record, and worl 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
Poseida Therapeutics is translating best-in-class gene engineering technologies into lifesaving cell therapies. The company is developing CAR T-cell immunotherapies for multiple myeloma, prostate and other cancer types, as well as gene therapies for orphan diseases. P-BCMA-101 is Poseida’s lead CAR-T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma. Poseida has assembled a suite of industry-leading gene engineering technologies, including the piggyBac™ DNA Modification System, TAL-CLOVER™ and Cas-CLOVER™ site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.