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Manufacturing Process Specialist
2 months ago
Poseida Therapeutics is on the lookout for a skilled and innovative Manufacturing Process Specialist to become a vital member of our MSAT team, focusing on the advancement of our allogeneic cell therapy initiatives. The selected candidate will be instrumental in assessing new methodologies aimed at enhancing process efficiency, ultimately leading to improved manufacturing outcomes. This role is crucial in orchestrating and executing process enhancement and donor evaluation studies in alignment with our clinical programs. The successful applicant will have the opportunity to significantly contribute to the overarching CMC project strategies within our newly established PD-MSAT group.
Key Responsibilities:
- Design and implement process optimization and enhancement studies to support allogeneic programs.
- Investigate alternative technologies to develop robust, reproducible, and scalable manufacturing processes.
- Oversee large-scale cell culture maintenance utilizing GRex, Wave, and stirred-tank bioreactors.
- Thoroughly analyze data, communicate findings, and prepare technical documentation.
- Contribute to the creation of standard operating procedures and facilitate technology transfer to internal or external partners.
- Conduct experiments to support manufacturing investigations and address out-of-specification results.
- Assist in Change Control initiatives and enact process modifications within a GMP framework.
- Support the preparation of regulatory submissions as required.
- Present findings and ideas in cross-functional team meetings.
- Develop and manage data tracking systems for clinical manufacturing and process development data, collaborating with external partners.
- Utilize statistical process control methodologies and JMP software for process monitoring.
- Identify and resolve out-of-trend results in manufacturing processes.
- Perform data analysis to support process investigations, validations, transfers, and regulatory submissions.
- Engage in a cross-functional development team to advance CMC activities.
Qualifications:
- Bachelor's or Master's degree in chemical engineering, bioengineering, or a related field, with a minimum of 5 years of relevant experience (an equivalent combination of education and experience may be considered). A Master's degree is preferred.
- Experience in bioprocessing, particularly in the development and manufacturing of cell-based or biologic therapy products, is highly desirable.
- Prior experience in Cell Therapy and/or MSAT is strongly preferred.
- Familiarity with cGMP requirements and ICH guidelines is advantageous.
- Exceptional communication, presentation, and facilitation skills are essential in a team environment.
- Strong scientific acumen, problem-solving abilities, and creative thinking skills are necessary to navigate a dynamic environment.
- Demonstrated ability to troubleshoot technical challenges and work with automation tools and software.
- Capacity to manage multiple tasks, organize time effectively, and plan work details independently.
- Proven ability to think creatively and adapt in a fast-paced, small company setting with minimal supervision.
- Physical capability to lift up to 50 pounds.
About Poseida Therapeutics:
Located in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical organization dedicated to leveraging our unique genetic engineering platform technologies to develop next-generation cell and gene therapies aimed at curing diseases. We are committed to making a significant impact on patients' lives through the advancement of our CAR-T therapies for various cancers and gene therapies for rare conditions. Our mission is to provide potential single-treatment cures for patients in need, overcoming the limitations of existing cell and gene therapeutic solutions.
At Poseida, we prioritize our people. Our team is driven by a passion for innovation and improving patient outcomes. We invite you to explore the opportunities for growth and impact within our organization.
