Our talented and tight-knit process development team is seeking a highly motivated and collaborative individual who possesses a strong work ethic, collaborative spirit, and is passionate about helping us deliver next-generation cell and gene therapies to patients. In this role you will have a direct impact on optimizing processes, developing new platforms, and integrating new technologies for cell and gene therapy manufacturing processes.
Poseida is seeking a highly motivated and talented individual to join the Manufacturing Science and Technology (MSAT) team in the Process Development organization. Ideal candidate will have a strong background in cell culture and biopharmaceutical process development from clinical to commercial stage. As a Senior Scientist/ Engineer in MSAT Process Development, you will provide leadership for experimental activities aiming at improving and optimizing GMP manufacturing processes for both autologous and allogeneic CAR-T product for cancer treatment. Additionally, you will support process characterization and process validations activities and regulatory submissions. The ideal candidate will have a demonstrated knowledge of phase appropriate process development as well as strong understanding of GMP environment for cell therapy/ biologics manufacturing.
Responsibilities may include but are not limited to:
- Design and lead process optimization studies to increase productivity, robustness, and/or yield of manufacturing operations while maintaining or improving product quality attributes
- Author and review technical documentation to evaluate impact of process changes and support change controls initiative
- Author and review IND sections to support IND amendment
- Design and implement business process to decrease COGs and streamlining of manufacturing procedures
- Author and review regulatory sections and dossiers
- Support Process Characterization (PC) activities to develop a thorough understanding of CPP and CQAs
- Support Process Validation and BLA readiness activities as required
- Provide technical support for root cause investigations, product impact assessments to support investigations and process changes compliant with quality requirements
- Experience with data analysis using software such as JMP, GraphPad, or Excel.
- Present main findings to internal and external partners as well as major stakeholder within the company
- May lead a team of research associates
- Other duties as assigned
Requirements, Knowledge, Skills and Abilities:
- Ph.D. in Biotechnology, Chemical Engineering or related discipline with 4 + years of industry experience or Bachelor's or Master's Engineering degree and 12+ years relevant experience in pharmaceutical process development/ MSAT (an equivalent combination of education and experience may be considered). Ph.D. is preferred.
- Experience with FMEA or other risk-based approaches to assess process performance is preferred
- Understanding of Quality by Design (QbD) principles to design and execute scaled-down process experiments is highly desirable
- Strong Technical Writing skills are required
- Prior experience with DoE and statistical data analysis for manufacturing is needed
- Proven track record with phase appropriate development process optimization
- Demonstrated experience with cell culture and aseptic processing
- Understanding of bioengineering principles is necessary
- Understanding of cGMP manufacturing and regulatory requirements for pharmaceuticals development is necessary
- Prior process characterization or process validation experience is highly desired
- Travel may be required up to 20% of the time
Salary Range: $100,000 to $125,363
The final salary 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.
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. See what our team has to say about our culture:
“My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we’re doing here and there’s so much camaraderie. It feels like one big enthusiastic family.”
“My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”
As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!