The PD Scientist/Engineer will be responsible for designing and performing laboratory activities to support process development and process characterization of Poseida’s existing and new cell-based therapeutic products. She/he will be responsible for cell processing, process engineering scale-up/scale-down, bioreactor process parameters, assessment of novel technologies, cryopreservation, and equipment maintenance. Under minimal supervision, she/he will be expected to design and perform experiments, organize and carefully document results, analyze and interoperate results, and communicate findings. The position will be based out of the newly created PD group and given an opportunity to contribute to the development of overall CMC project strategies.
These may include but are not limited to:
- Independently design and execute process development studies using Design of Experiment (DOE)
- Analyze data, communicate results, and author technical reports
- Evaluate alternative technologies to create robust, reproducible, and scalable next generation manufacturing processes
- Perform CAR-T manufacturing process to support process development activities
- Assist in the development of standard operating procedures, analytical test methods, analytical sampling plans, and technology transfer to internal or external manufacturers
- Present ideas and data in team meeting and cross-functional meetings. Be an active participant and intellectual leader
- Critically evaluate new technologies and concepts. Stay current with relevant literature
- Provide leadership to more junior team members
- Follow SOPs relating to safety, laboratory work, and data recording
- 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
- D. in Immunology, cancer biology, or engineering science with 1-3 years of related industry experience (an equivalent of education and experience may be considered)
- Experience with process characterization, scale-up and/or technology transfer preferred
- Familiarity with development and /or commercialization of cell-based therapeutics
- Basic understanding of cGMP requirements
- Experience using DOE
- Ability to multitask, independently organize time, and plan specifics of work
- Excellent communication and facilitation skills demonstrated in a team environment
- Willingness to think outside the box, be creative and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- 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.