Senior Process Engineer - MSAT

Your Impact

Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements.

Our tight-knit, agile, and fun MSAT team is looking for someone who has a strong work ethic and wants to be a part of a collaborative team.

In this role, you will have a direct impact on establishing the next generation cell expansion platform for Poseida to support commercialization of the company's growing allogeneic cell therapy pipeline.

This individual will lead upstream process development and new technology evaluation initiatives to transition current production processes to single use, closed system bioreactors.

You will have an opportunity to learn and advance in your career as this group is forward-thinking and fully supportive of development.

We understand the meaning of team and are looking for an individual that wants to be a part of something bigger and a driving force in changing the lives of cancer patients.

Position Summary

The Senior Process Engineer is part of the dedicated bioreactor development group within the Poseida MSAT Team and charged with leading upstream process development activities focused on transitioning production of the company's cellular CAR-T technology into advanced culture systems designed to improve process control / monitoring and increase final product batch yields.

This individual will lead a small team of process engineers and development associates in the optimization, scaleup, and characterization of the cell production process in single use bioreactors and tech transfer of the process to Poseida's internal cGMP Pilot Plant or external partner site.

Responsibilities may include but are not limited to :

• Your responsibilities will include process design / development through technology evaluation activities, designing and executing development studies, authoring study protocols and reports, enabling technology transfer to clinical manufacturing, and ensuring that the developed processes, design changes, technologies, and materials / reagents meet internal facility fit and regulatory requirements.
• The incumbent will work closely with teams from Process Development, Analytical, Validation, Information Technology, Facilities Engineering, Finance, Supply Chain, and external collaborators to craft and deploy allogeneic cell therapy platforms aimed at advancing Poseida's portfolio.
• Design and lead feasibility, comparability in support of IND-Amendments and change control studies to support process or raw material changes.
• Lead the execution of process development projects from proof-of-concept design and development to implementation and training for the receiving site.
• Close collaboration with internal and external partners is expected, as well as the application of first principles and engineering fundamentals to achieve the team's allogeneic technology initiatives.
• Assist with startup activities of a new cGMP facility by collaborating with PD, MSAT, Facilities, and Quality departments.
• Author process development study plans, development reports, SOP's, batch records, FMEA's, and other documentation to support tech transfer.
• Ensure successful clinical manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
• Design manufacturing processes and develop process improvements / efficiencies including feasibility testing and implementation of new technologies and process automation.
• Design and execute process development studies, analyze data, review and approve technical documentation.
• Design and execute process characterization studies to develop a thorough understanding of critical attributes and key operating and performance parameters.
• As a Senior Process Engineer, you may lead a small team tasked with development and implementation of new technologies and capabilities to improve process design and scale-up of allogeneic immune cell manufacturing processes.
• Communicate results and experimental outcomes into technical reports and presentations including recommendations of next steps.
• Collaborate and support internal and external partners and vendors.
• Support onboarding and mentoring of new team members.
• Always ensure critical thinking with the goal of optimizing and improving processes / procedures.

Requirements, Knowledge, Skills and Abilities :

• Bachelor's / Master's degree in a similar field of study and 12+ years laboratory hands-on experience in process development, MSAT, process engineering, or similar position in upstream processing (inoculation to product harvest) An equivalent combination of education and experience may be considered.
• Experience in single-use stir tank bioreactor process development for scale-up expansion is required.
• Working understanding of the overall bioprocessing workflow including upstream cell culture, process analytics, data analysis, various lab and bioprocess instruments / equipment, and MES software.
• Experience in process development of allogeneic immune cell therapies is a plus.
• Knowledge of processes for advanced therapies such as cell therapy, gene therapy, and nucleic acids is a plus.
• Experience with perfusion technologies to enable bioreactor process intensification is a plus.
• Established cell culture and aseptic processing techniques in a BSC such as cell passaging, sampling, fluid handling, media formulation, reagent and vial management, and cryopreservation.
• Understanding of cell biology principles, sub-population cell types, differentiation, phenotype markers, and metabolic pathways is a plus.
• Knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals.
• Use of statistical tools (JMP, SIMCA) and design of experiments is highly preferred.
• Capable of performing design of experiments and post-experimental data analysis and decision making.
• Mastery of scientific and engineering principles.
• Well-developed computer skills, ability to multi-task, and self-organize.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to function efficiently and independently in a changing environment.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description; ability to handle ambiguity in task and project definition.

Who We Are and What We Do

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure.

We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases.

Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.

At Poseida we put people first. Our team is passionate about improving patients' lives through innovation. As we advance our compelling pipeline, there are endless opportunities for impact and growth.

We encourage you to apply today!

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