Poseida is seeking an outstanding candidate to join our growing process development team. The Process Development Scientist will be responsible for directing product candidates through process development and support process transfer to Poseida’s cell therapy contract manufacturing organizations (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.
These may include but are not limited to:
- Responsible for developing phase-appropriate cell therapy production processes using Quality by Design (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
- Manage technical transfer of Poseida’s cell therapy products with CMOs and act as process development subject matter expert
- 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
- Keep current with process technology trends and best practices for cell therapy process development and GMP manufacturing
Requirements, Knowledge, Skills and Abilities
- PhD in immunology or related discipline with 3+ years post-graduate work experience (an equivalent combination of education and experience may be considered)
- Experience developing CAR-T or hematopoetic stem cell production processes.
- 2 plus years of experience with GMP manufacturing of cell therapy or biological products is desired.
- Experience with working with contract manufacturing organizations, vendors and partners.
- Experience with analytical methods, such as qPCR, FACS, ELISA, and RNA expression.
- 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.
- Outstanding written and oral communication skills are essential; report, 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
- Ability to travel up to 20% of time
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.