Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our Quality team. The Senior Quality Specialist will be a key 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:
- Effectively collaborate with internal Research and Process Development teams as well as with Poseida’s Contract Manufacturing Organizations
- Reviews executed production batch records and associated data for product release. Ensures records meet cGMP expectations. Reviews data obtained for compliance specifications and reports abnormalities.
- Responsible for ensuring out of specification results and deviations are fully investigated and appropriate CAPAs are assigned. Ensure timely closure of investigations and timely implementation of CAPAs
- Reviews and revises master batch production records and quality control specifications for in-house or external contract manufacturing organizations
- Generates and maintains Quality metrics for identified internal and external critical quality attributes.
- Responsible for adhering to quality agreements
- Support internal Quality System audits as requested
- Perform/support external supplier and vendor audits as required
- Review internal and external change controls
- Performs logbook documentation audits for cGMP regulated logs as requested
- Creates, revises, and reviews SOPs, Forms Work Instructions and other controlled documents
- Align daily actions with department goals and company culture
Requirements, Knowledge, Skills and Abilities
- Bachelor’s degree in Life Sciences discipline and a minimum of 5 plus years of experience in a GMP setting (an equivalent combination of experience and education may be considered)
- Working knowledge of cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices.
- Detail oriented with strong written and verbal communication skills
- Basic computer skills in Excel, PowerPoint, and word processing
- Ability to work independently, within prescribed guidelines, or as a team member
Preferred Experience and Skills:
- Knowledge of Fill Finish and Biologics production environments strongly preferred
- Working knowledge of cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices as well as the ability to train staff on the requirements of the regulations
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.