We are seeking an experienced and motivated Associate to join the Process Development teams at Poseida Therapeutics. The focus of this position is to introduce new technologies and develop next generation manufacturing processes for our novel gene-modified cell-based therapeutic products. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. Additionally, s/he will be involved in tech transfer for GMP manufacturing and writing of SOPs, batch records, and CMC sections for the IND.
These may include but are not limited to:
- Design and execute process development studies via quality by design (QbD) strategies and classical design of experiment (DoE) approaches
- Evaluate alternative technologies to create robust, reproducible, and scalable next generation manufacturing processes
- Sets up, monitor, sample and analyze cell culture processes
- Performs assays for process assessment and product characterization
- Document laboratory procedures and experiments with great attention to detail in laboratory notebooks
- Assist in the development of standard operating procedures, analytical test methods, and analytical sampling plans
- Work with R&D teams to gain deeper understanding of the process challenges and of the process-to-process product quality attributes variability
Requirements, Knowledge, Skills and Abilities
- BS/MS in Biomedical, Bioprocessing, Chemical Engineering or equivalent with at least 3-5 years of relevant experience (an equivalent combination of education and experience may be considered) in bioprocessing or biological sciences with a primary focus on the development, manufacture, distribution and delivery of cell-based or biologic therapy products
- Demonstrated excellent aseptic technique. Proficient in cell culture of human lines and primary cells
- Experience designing and executing process validation experiments using statistical multi-parameter design methods such as DOE or JMP
- Proven experience in biological or cell therapy process development or cGMP clinical manufacturing
- Experience with cell separation, culture, expansion, and manipulation of T cells. Experience with stem cells, gene therapy, or nanotechnology is a plus
- Experience in human T cell biology with demonstrated proficiency in a broad range of cellular immunology techniques, including flow cytometry and in vitro T cell functional assays (cytotoxicity, ELISA, proliferation, Luminex)
- Excellent communication skills, data presentation and interpersonal skills
- Basic computer skills in Excel, PowerPoint, and word processing
- Attention to detail, initiative, and strong organizational skills
- Experience with drafting SOP and batch record writing. Manufacturing/cGMP experience is a plus
- Travel may be required up to 10-20% of the time
- Must be physically capable to lift 50 pounds
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.