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.
These may include but are not limited to:
- 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
Requirements, Knowledge, Skills and Abilities
- 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
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 email@example.com.