Process Development Scientist II
San Diego, United States
Job Description
In this role, you will join a collaborative and motivated team focused on enhancing Poseda’s platform for developing next-generation cell and gene therapy products across various allogeneic cell therapy programs. You will adopt a phase-appropriate approach to process development at different stages. Your contributions will directly impact the generation of clinical materials that support Poseida’s mission to cure cancer patients. This position offers an opportunity for professional growth in a forward-thinking environment that values development. We seek an individual who is eager to be part of a larger mission and play a key role in transforming the lives of cancer patients.
Position Summary
This position plays a key role in collaborating with the R&D and MSAT teams to develop, optimize, and integrate cutting-edge processes and technologies for cell and gene therapy, with a primary focus on allogeneic CAR-T cells. The individual will lead efforts to enhance current production methods, while also spearheading the development of innovative manufacturing processes. Responsibilities include conducting research, evaluating new platform technologies, troubleshooting technical challenges, and working with automation tools. Strong communication and presentation skills are essential, as is the ability to meet tight deadlines. This position is based at our headquarters in San Diego, CA
Responsibilities
These may include but are not limited to:
- Lead process development and optimization for cell and gene therapy products from research to IND submissions.
- Develop scalable platforms for gene delivery, focusing on electroporation and non-viral methods.
- Drive the integration of innovative manufacturing technologies for robust and scalable processes.
- Collaborate with R&D, MSAT, and manufacturing teams to solve complex process challenges and improve product quality.
- Design and execute advanced experiments using DOE to optimize processes.
- Analyze data, author technical reports, and present findings to internal and external stakeholders.
- Oversee regulatory documentation, including SOPs and batch records, ensuring compliance.
- Manage technology transfer and training for GMP production.
- Anticipate and resolve critical manufacturing issues with cross-functional teams.
- Prioritize and allocate resources for high-impact projects.
- Mentor and lead junior scientists and associates, fostering a culture of growth and innovation.
- Provide strategic input on technology development and product pipeline.
Requirements, Knowledge, Skills and Abilities
- PhD in immunology, cancer biology, or engineering science with 2 or more years of related experience within process development (or an equivalent combination of education and experience).
- Preferred experience in process development, characterization, scale-up, and/or technology transfer.
- Expertise in working with immune cells, particularly CAR-T or primary cells, including culture, expansion, harvest, and formulation.
- Basic understanding of cGMP requirements.
- Strong multitasking and time-management skills, with the ability to work independently.
- Hands-on experience with assays using human whole blood, PBMCs, and purified T cells, including multi-color immunophenotyping, lymphocyte subset characterization via flow cytometry, and functional analyses such as cytotoxicity and ELISA assays.
- Creative problem-solving skills and adaptability in a fast-paced environment with minimal supervision, with the ability to adjust to shifting priorities.
- Proven ability to organize, communicate, and present program progress and key data to diverse stakeholders.
- Excellent oral and written communication skills; able to work independently and collaboratively.
- Experience with biopharmaceutical product and process development, process engineering, aseptic fill/finish operations, and cGMP knowledge.
- Capable of lifting up to 25 pounds.
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Career Focus: Analyst, Drug Development, Scientist
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