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Senior Bioprocess Engineer
2 months ago
Join our dynamic and collaborative MSAT team at Poseida Therapeutics, where we are seeking a dedicated professional with a strong work ethic. In this pivotal role, you will directly contribute to the advancement of our next-generation cell expansion platform, essential for the commercialization of our expanding allogeneic cell therapy pipeline.
The Senior Process Engineer will spearhead upstream process development and evaluate new technologies to transition existing production methods to single-use, closed-system bioreactors. This position offers an excellent opportunity for career growth within a forward-thinking team that values development and innovation.
We are looking for someone who understands the essence of teamwork and is eager to be a driving force in transforming the lives of cancer patients.
Position SummaryThe Senior Process Engineer is a key member of the bioreactor development group within the Poseida MSAT Team, responsible for leading upstream process development activities aimed at transitioning the production of our cellular CAR-T technology into advanced culture systems. These systems are designed to enhance process control and increase final product batch yields.
In this role, you will lead a small team of process engineers and development associates in optimizing, scaling up, and characterizing the cell production process in single-use bioreactors, as well as transferring the process to Poseida's internal cGMP Pilot Plant or external partner sites.
Key Responsibilities- Design and develop processes through technology evaluation activities, executing development studies, and authoring study protocols and reports.
- Facilitate technology transfer to clinical manufacturing while ensuring compliance with internal facility fit and regulatory requirements.
- Collaborate closely with teams across Process Development, Analytical, Validation, IT, Facilities Engineering, Finance, Supply Chain, and external partners to create and implement allogeneic cell therapy platforms.
- Lead feasibility and comparability studies to support IND-Amendments and change control initiatives.
- Manage process development projects from initial design to implementation and training for receiving sites.
- Assist with the startup activities of a new cGMP facility by collaborating with various departments.
- Author process development study plans, reports, SOPs, batch records, and other documentation to support technology transfer.
- Ensure successful clinical manufacturing runs by assessing risks and troubleshooting equipment and process issues.
- Design manufacturing processes and implement improvements, including feasibility testing and new technology integration.
- Communicate experimental results through technical reports and presentations, including recommendations for next steps.
- Support the onboarding and mentoring of new team members while fostering a culture of critical thinking and process optimization.
The ideal candidate will possess a Bachelor's or Master's degree in a relevant field and have over 12 years of hands-on laboratory experience in process development, MSAT, or process engineering, particularly in upstream processing.
Key qualifications include:
- Experience in single-use stir tank bioreactor process development for scale-up expansion.
- Understanding of the bioprocessing workflow, including upstream cell culture and process analytics.
- Familiarity with allogeneic immune cell therapies and advanced therapies such as gene therapy.
- Knowledge of cGMP manufacturing and regulatory requirements.
- Proficiency in statistical tools and design of experiments.
- Strong problem-solving skills and the ability to work independently in a dynamic environment.
At Poseida Therapeutics, we are committed to making a significant impact on patients' lives through innovative therapies. Our team is passionate about developing CAR-T therapies for various cancers and gene therapies for rare diseases, with the ultimate goal of delivering potential single-treatment cures.