Poseida Therapeutics is seeking an experienced, talented, and detailed-oriented individual to join the Technical Operations team as a Site Head for the planned Pilot cGMP manufacturing facility supporting our CAR-T cell programs. Reporting to the VP of Technical Operations, this person will own the end-to-end process from taking an autologous/allogeneic CAR-T cell candidate from early process development to clinical manufacturing at the Pilot plant. This opportunity will be based in San Diego, CA, and will lead all anticipated manufacturing operations and support functions. During the planning, construction, and start-up phase, the Site Head with be directly responsible for the achievement of the project and start up objectives that have been established for the facility. The successful candidate with interface directly with appropriate regulatory agencies to ensure the new facility is built-out, inspected, and approved in a timely fashion.
These may include but are not limited to:
- Develop and implement organization-wide and site-specific strategies for product development and manufacturing, ensure success of all production activities and projects including build-out, commissioning and qualification, facility start-up and reliable operations
- Responsible for long-range strategic planning for the manufacturing site and contribute to the development and execution of Poseida’s manufacturing and supply chain strategy
- Lead the execution of CAR-T cell development and manufacturing activities to support clinical development from IND through Phase 2
- Build a high performing team by recruiting and developing talent, ensuring the development and implementation of training required to fully qualify staff for facility startup and routine operations
- Evolve the functional strategy for early stage products, rapid transition of early-stage candidates into the clinic, and evolution of next generation and novel platform elements into the regulated environment.
- Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements and drive operational excellence, flawless execution and continuous improvement
- Provide leadership, direction, technical support and closely oversee and upstream and downstream process development and characterization, from pre-clinical through PPQ as well as manufacture of non-GMP materials for non-clinical and research studies.
- Lead efforts to identify and champion new methodologies, technologies, and/or improved production modalities to increase yields, potency, and purity.
- Identify risks and drive continuous improvement in the manufacturing processes through technological innovation, operational improvement, and alignment with regulatory and commercial manufacturing requirements.
Commit to safety and ensure ultimate workplace safety and security remains uncompromised
- Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement
- Site representative before the relevant State and local authorities and inhabitants
Requirements, Knowledge, Skills and Abilities
- Minimum of Bachelor’s degree in engineering or related field with at least 15 years of relevant experience in manufacturing or process development within a GMP facility biotech or pharmaceutical environment (an equivalent combination of education and experience may be considered)
- Experience within a CAR-T manufacturing environment is preferred
- Demonstrated leadership and proven track record and expertise in biopharmaceutical facility design, construction and operations
- Strong development experience in bringing cell therapies from Phase I to pivotal, particularly in the areas of process characterizations, technology transfers and process validation
- Experience with developing and optimizing both upstream and downstream unit operations
- Proven experience with process/tech transfer to internal and/or external GMP manufacturing organizations
- Demonstrated experience with applying Quality by Design (QbD) concepts and statistical process design and analysis
- Strong understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
- Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
- Demonstrated team player with ability to build and sustain organization respect and trust at all levels
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast paced entrepreneurial environment
- Ability to multitask and ensure flexibility in a dynamic team environment
- Keeps current on professional knowledge, expertise and best practice
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.