Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our 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 appropriately to meet requirements for the 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 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
- Develop platform production processes and ensure processes are suitable for late-stage clinical development and commercial production
- Responsible for process improvement initiatives to streamline manufacturing, or improve process robustness or cost of goods
- Lead in the start up of Poseida’s cell therapy process development laboratory
- 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 circumvent CMC issues to achieve company goals and objective.
- Provide effective leadership and coaching to the team to ensure the development and growth its people
- 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. Candidates with Bachelor of Science or Masters degree in immunology, chemical engineering, or other related discipline with 6+ years relevant industry experience will be considered.
- Experience developing CAR-T or hematopoetic stem cell production processes.
- Experience with GMP manufacturing of cell therapy or biological products is a plus. The ideal candidate will have experience with working with contract manufacturing organizations, vendors and partners.
- Experience with analytical methods, such as qPCR, FACS, ELISA, gel electrophresis.
- 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%
- Outstanding written and oral communication skills are essential
- Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management
- 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 editing technologies into lifesaving treatments. The company is developing CAR T-cell immunotherapies for multiple myeloma and other cancer types, as well as gene therapies for orphan diseases. Poseida is also partnered with Janssen Biotech to develop allogeneic CAR T-cell therapies using Poseida’s gene editing platform. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBacTM DNA Modification System, XTNTM TALEN and NextGENTM CRISPR site-specific nucleases, and Footprint-FreeTM Gene Editing (FFGE). For more information, visit www.poseida.com