Poseida Therapeutics, Inc. is seeking an outstanding candidate to direct our Cell Therapy Development. The Director will be responsible for overseeing and leading cell therapy product candidates through process development and manufacturing. This position will be responsible for process development, tech transfer and CMO management groups. This position will be responsible developing Poseida’s platform cell therapy production processes and ensuring processes and supporting analytical methods mature appropriately to meet requirements for the stage of product development. The Director of Cell Therapy Development is expected to keep current with process technology trends and best practices for cell therapy process development and manufacturing. This position will report to the Vice President of Technical Operations.
Primarily, the role will:
- Build, lead, manage and develop a best-in-class, high-performance cell therapy development organization to support the development and manufacturing of the existing and future CAR-T therapy products.
- Manage technology transfer and manufacturing for all cell therapy-related contract manufacturing organizations, including raw material suppliers
- Responsible for ensuring clinical supplies are available in a timely manner to support clinical programs
- Develop and maintain product and production plans that are in alignment with the requirements of the clinical program
- Develop phase-appropriate clinical production processes using QBD principles
- Provide effective leadership and coaching to the team to ensure the development and growth its people.
- Establish and maintain strong collaborative relationships with company’s quality control units
- Responsible for closely interacting with Poseida research group and developing a best-class platform production processes for cell therapy products and enhancing process design and control for late stage clinical and commercial manufacturing, with cost of goods being considered
- Contribute to regulatory filings and interact with regulators as requested by the head of Regulatory to ensure timely start of clinical trials and establishing a strong collaborative relationship with regulatory agencies
- Provide strategic and creative solutions to circumvent CMC issues to achieve company goals and objective.
- Support the design, development, build-out, and validation of the company’s future clinical/commercial manufacturing facility
- Develop timelines, budget and resource requirements for all cell therapy projects and prospective projects under consideration
- Responsible for leading high impact cross functional initiatives
Poseida Therapeutics is a spin out of Transposagen Biopharmaceuticals that utilizes best-in-class, proprietary genome editing technologies to develop targeted, life-saving therapeutics in areas of high unmet medical need. The company has demonstrated proof-of-principle that validates the potential of our differentiated genome engineering technologies and their therapeutic applications. Poseida Therapeutics’ technology platforms have broad applicability and the company’s long-term goal is to apply its proprietary gene editing technologies to a broad range of human diseases. The initial applications of Poseida’s technologies will be in gene therapy and CAR-T product candidates for pediatric orphan liver disorders and cancer, respectively.
Required Experience and Skills:
- Bachelor of Science degree in chemistry, chemical engineering, microbiology, biology or other related discipline. An advanced degree, either M.S. or Ph.D. is desirable.
- Minimum of 5 years of cell therapy process development or GMP manufacturing experience, and 8 to 15 years cumulative experience in process development or manufacturing of biologics. The ideal candidate will have significant experience with development and manufacturing of autologous cell therapy product(s) for clinical supply.
- Experience with extensive utilization of contract manufacturing organizations, vendors and partners is preferred. The ideal candidate will also have experience with in-house manufacturing of cell therapy or biological products.
- Experience with analytical methods, such as qPCR, RT-PCR, FACS, ELISA. Experience with testing in a GMP setting is a plus.
- Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas.
- Minimum of 5 years of experience of managing and leading direct reports
- Strong general management skills and has ability to lead by example, attract and develop talent, build interdependent partnerships and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.
- Excellent leadership, managerial 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, directors, and corporate partners
- High sense of integrity and professionalism and the ability to work well in a cross functional team environment