Poseida Therapeutics, Inc. is seeking an exceptional candidate to join our Quality team in San Diego, CA. The Associate Director, External Quality will develop, monitor, and maintain all aspects of the quality system as it relates to oversight of Contract Development Manufacturing Organizations (CMDO) to ensure compliance with applicable FDA and international regulatory requirements. This person will be responsible for managing Quality systems including Batch Release, Change Control, Deviations and CAPAs as they relate to governance of CDMOs supplying Poseida with cGMP products. This role will regularly interact with and oversee our contract manufacturing organization on cGMP compliance-related issues. This role reports to the Vice President of Quality.
These may include but are not limited to:
- Review and approve proposed changes to Posedia-specific master batch production records, standard operating procedures and quality control specifications from external contract manufacturing organization.
- Provide Quality oversight as required for product stability programs established at CDMOs for Poseida’s pipeline.
- Responsible for management of personnel who review production batch records and associated data for product release. Determines if records are within range of cGMP expectations. Reviews data obtained for compliance specifications and report abnormalities.
- Evaluates the impact of deviations and adverse events to product quality.
- Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Oversight and follow up from CDMO audits
- Approval of cGMP labels/galley proofs for CDMO.
- Align daily actions with department goals and company culture.
Requirements, Knowledge, Skills and Abilities
- Minimum of Bachelor’s degree in a scientific discipline
- A minimum of 10 years in the Pharmaceutical/Biotechnology industry with progressive responsibilities managing functional areas and personnel in a Quality department.
- In-depth understanding 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.
- Clinical product batch release experience required and Commercial product release is strongly preferred.
- Experience in investigations writing and review required.
- Experience with third party testing vendors and quality control release assays preferred.
- Knowledge of Fill Finish and Biologics production environments strongly preferred.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Travel may be required up to 25% of the 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.