We are seeking an experienced and motivated Process Development Associate to join the late-stage Process Development & Manufacturing Sciences and Technology(MSAT) team at Poseida Therapeutics. The successful candidate will join a multidisciplinary team to support the allogeneic efforts for Poseida’s allogeneic programs. This is a hands-on, combination of laboratory-based and data analysis role where the candidate will support the introduction and evaluation of new technologies into Poseida’s allogeneic processes and play a key role in process understanding. The ideal candidate will have a proven track record of innovation, knowledge in process and analytical development, extensive cell culture experience, statistical process control methodologies, statistics, data analysis, and is excited to take on new challenges in a fast-paced and dynamic environment. Additionally, the Process Development Associate will be involved in donor characterization efforts, evaluating efficacy of CAR T cells in animal models, and may assist in the drafting of SOPs and production batch records of ongoing process changes.

Responsibilities may include but are not limited to:

• Design and execute process development, optimization, and characterization studies independently and under supervision to enhance process understanding initiatives in Poseida’s non-GMP laboratories
• Establish process parameters and generate data to identify potential process failure modes and support implementation of process changes throughout clinical development of allogenic CAR T cell products
• Assist in evaluating alternative technologies and systems to create robust, reproducible, and scalable next generation manufacturing processes
• Maintenance of large-scale cell cultures in GRex, Wave and stirred-tank bioreactors
• Phenotypic and functional characterization utilizing flow cytometry and cell-based assays
• Assist senior members of the Process Development & MSAT team in developing processes and analytical testing as required
• Troubleshoot cell processing equipment independently
• Perform assays/product testing via SOP for in process and final product testing, as needed
• Document laboratory procedures and experiments with great attention to detail in laboratory notebooks
• Assist in the development of standard operating procedures, and technical documentation
• Schedule lab equipment and perform routine maintenance
• Develop and maintain data tracking systems for clinical manufacturing process data and process development data, including collaborating with external partners
• Perform process monitoring using statistical process control methodologies and JMP statistical software
• Identify and troubleshoot out of trend results in manufacturing processes
• Perform data analysis supporting process investigations, validations, process transfers, and regulatory submissions
• Participate in a cross functional development team to advance CMC activities

Requirements, Knowledge, Skills and Abilities

• Bachelor’s or Master’s degree in Biological Sciences, Biomedical Engineering, Immunology or other related scientific field with 0-2 years of relevant biopharmaceutical experience (an equivalent combination of education and experience may be considered)
• Bioprocessing with a primary focus on the development, manufacture, distribution and delivery of cell-based or biologic therapy products preferred
• Prior Cell Therapy experience and/or MSAT experience highly desired
• Proven track record of contributing to projects in immunology, cancer biology, or cell biology is a plus
• Prior experience running multicolor flow cytometry assays and performing data analysis is a plus
• Hands-on experience with wave, stirred-tank bioreactor, and/or Grex platforms is a plus
• Demonstrated excellent aseptic technique and cell culture proficiency
• Experience with cell separation, cell processing, cell culture, expansion, and manipulation of T cells
• Basic understanding of cell biology with cellular immunology techniques, such as flow cytometry and in vitro T cell functional assays (cytotoxicity, ELISA, proliferation, Luminex) is a plus
• Proven hands-on experience with data analysis and storage software including Microsoft Excel, JMP, experience other data visualization software (GraphPad Prism, Power BI, Tableau, R, etc) is a plus
• Knowledge of basic statistical concepts
• Knowledge of GMP data management including data verification, data integrity, and GMP data workflows is a plus
• Excellent communication skills, data presentation and interpersonal skills
• Basic computer skills in Word, Excel, PowerPoint, and word processing
• Attention to detail, initiative, and strong organizational skills
• Experience with drafting SOP and batch record writing is a plus
• Manufacturing/cGMP experience is a plus
• Must be physically capable of lifting 25 pounds

TEMPORARY Process Development Associate Pay Rate: $31.73/hour to $39.90/hour

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.