Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our Quality team. The Quality Control Analyst will be a member of a dynamic team that ensures the safety of our products at various points during the manufacturing process and confirms it meets with predefined criteria.
These may include but are not limited to:
- Lab-based position that will involve hands-on processing of drug product at various stages of the manufacturing process as well as the final product for our clinical trial
- Supports the Research Operations Product Pipeline Support team by performing in process and release testing
- Support raw material testing
- Skilled in aseptic technique and have experience working in or supporting cGMP manufacturing facilities
- Ability to create and draft standard operating procedures and test methods
- Ability to utilize quality systems procedures such as Deviation, OOS, and CAPA
- Good oral and written communication skills, and will work with minimal supervision to execute testing, follow written test methods and protocols, collect data, and prepare reports
Requirements, Knowledge, Skills and Abilities
- Bachelor’s degree in Life Sciences discipline with 3 plus years of experience in a GMP setting (an equivalent combination of education and experience may be considered)
- Excellent aseptic technique
- Experience in biologicals process development or cGMP manufacturing environment
- 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
- Able to travel up to 10%
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.