Poseida is seeking an exceptional candidate to join our Process Development Team. The Associate Director, Process Analytical will be responsible for generating a team in development of analytical methods for cell therapy process and product development to support Process development and clinical manufacturing for our CAR-T programs.
These may include but are not limited to:
- Establish and lead the process analytical capabilities across process development for our products.
- Recruit and manage a team of Analytical Process Scientists
- Establish methods for characterization of process and product and final product release for CAR-T product or other cell and gene therapy products
- Lead the transfer of test methods to collaborators and CDMOs
- Drive the development of QC-friendly late-stage product release assays and new analytical methods to improve understanding of Poseida’s products
- Lead the development of analytical and functional testing methods for Poseida’s critical raw materials.
- Support Quality Control and Quality Assurance as necessary and participate in the technical assessment of Out of Specification and Non-Conforming investigations.
- Establish and maintain strong collaborative relationships with company’s R&D and Quality Control units
- Contribute to regulatory filings as requested by Regulatory
Requirements, Knowledge, Skills and Abilities
- Masters or PhD in immunology, microbiology, molecular biology or other related discipline with a minimum of 8 years of industry experience in analytical development for cell and gene therapies (an equivalent combination of education and experience may be considered).
- Proven leadership experience with recruiting, managing and developing teams
- Industry experience with development of analytical methods, such as qPCR, qRT-PCR, ELISA, cell-based potency assays, flow cytometry, RNAseq, and gel electrophoresis.
- Experience developing assays for Quality Control testing of drug substance or drug product
- Ability to work in a fast-moving dynamic small company environment.
- 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
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.