Position Summary:

We are seeking a motivated Scientist to join the Analytical Development team at Poseida Therapeutics in our Process Development department. This position works with the technical operations team to develop and/or optimize cell-based assays for cell product and raw materials characterization and release. The Analytical Development Scientist participates in laboratory activities to support process development, evaluate and develop assay methods, and perform raw material and product characterization for CAR-T cell products. He/she is also involved in assay optimization, standardization and transfer to internal or external QC labs. Under minimal supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports/CMC sections of IND, and communicating findings. The ideal candidate can apply their skill set and knowledge in process and analytical development and is excited to take on new challenges in a fast-paced and dynamic environment.

Responsibilities:

May include but are not limited to:

• Develop or adapt analytical methods for cell product characterization and release as well as raw material qualification by designing and executing studies using design of experiment (DoE)
• Develop critical reagent specifications and ensure quality of critical reagents used in manufacturing process of CAR-T cells and analytical assay meet established criteria.
• Independently plan and execute testing of critical reagents by understanding their role in the process and determining fit for purpose.
• Design and execute experiments to optimize current analytical methods. Make recommendations to key stakeholders at Poseida and our CROs.
• Manage reagent lifecycle during drug development by trending lot to lot variability and evaluating capability of reagents.
• Independently research, plan and execute experiments and analyze data to determine next course of action and make recommendations to internal and inter departmental audiences.
• Execute routine laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations.
• Perform data analysis and document study outcomes and conclusions, summarize, present, and recommend decisions to key stakeholders.
• Design, execute, and approve method development, transfer, and qualification in support of process development, product characterization, product release and stability.
• Author assay development and qualification reports and regulatory documents. Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.
• Work with a cross-functional team to advance development of cell therapy products.
• Support training of junior Research Associates or other team members, as needed.

Requirements, Knowledge, Skills and Abilities:

• Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Molecular Biology or Biochemistry) with 0-2 years of relevant experience (a combination of education and experience may be considered).
• The ability to develop analytical assays for characterization of critical raw materials using molecular biology techniques (primer design, PCR, NGS).
• Experience in cell-based assay development, potency assay development, analytical method development and CGMP guidance, preferably in the gene and cell therapy industry.
• Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE).
• Experience in analytical techniques such as qPCR, ddPCR, RT-PCR, Fragment Analyzer, Flow cytometry, ELISA, SDS-PAGE, Nanodrop.
• Experience with the development and optimization of NGS assay protocols, HPLC, SPR, a plus.
• Prior experience with CAR-T manufacturing process (leukopak processing, T cell isolations, use of Prodigy) is a plus.
• Ability to interpret and apply ICH guidance, cGMP, USP, regulatory requirements and industry best practices for analytical method development, technology transfer, method qualification/validation and process development.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent interpersonal, verbal and written communication skills are essential.
• Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description.
• Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Attention to safety, good laboratory practice, and good documentation practice.
• Experience with statistical programming or software (e.g.JMP, R) a plus.