Poseida is seeking a highly motivated individual to join our Process Development Team. Ideal candidate will have a proven track record of cell culture experience and statistical analysis to work on innovative T cell process for cancer treatment. As a Process Engineer in Late Stage Process Development, you will provide process development support for technology transfers, process characterization and process validations for autologous and allogeneic T cell therapy products. The ideal candidate will have a demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, cell therapy products and process development.
These may include but are not limited to:
- Draft Process characterization studies protocols and reports and PC/ PV related regulatory documentation
- Hands on execute and collaborate to support Process Characterization (PC) and -pre commercial process improvements to develop a thorough understanding of CPP and CQAs
- Perform process analysis and statistical design of experiments (DOEs) using JMP and other statistical software
- Review and manage execution of protocols at CMOs intended to demonstrate improvement in productivity, reliability, and/or yield of manufacturing operations while maintaining or improving product quality attributes
- Write and review technical documentation from writing technical SOPs, review manufacturing batch records, technical reports and summary reports
- Support Process Validation activities in conjunction with CMOs
- Participate and influence a cross-functional development team to advance CMC activities
- Other duties as assigned
Requirements, Knowledge, Skills and Abilities
- Master’s Degree in biomedical engineering, chemical engineering or related discipline with 5 plus years of experience within pharmaceutical manufacturing (an equivalent combination of education and experience may be considered)
- Proven hands on experience with statistical software (JMP, Minitab or similar) for both process analysis and statistical experimental design
- Proven experience with technology transfer & process development experience
- Demonstrated experience with cell culture and aseptic processing experience
- Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals development is desired
- Experience with bioreactors is desired
- Prior process characterization or process validation is desired
- Understanding of late stage process development regulatory requirement is a plus
- Travel may be required up to 20% 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 firstname.lastname@example.org.