Process Development Scientist
San Diego, United States
Job Description
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 phase-appropriate process development and optimization for cell and gene therapy products from research handoff to IND filings.
- Develop scalable platforms for delivering transposon/transposase constructs into T cells via electroporation and other non-viral gene delivery systems.
- Evaluate and implement alternative technologies to establish robust, reproducible, and scalable next-generation manufacturing processes.
- Collaborate with R&D teams to address process challenges and understand product quality variability across processes.
- Independently design and execute process development studies using Design of Experiment (DOE) and apply statistically sound methods for study design and data analysis.
- Analyze data, communicate results, and author detailed technical reports.
- Present key findings to internal teams, external partners, and major stakeholders.
- Author and review technical documentation, including standard operating procedures and batch records.
- Lead technology transfer to both internal and external manufacturing teams and provide training for GMP production.
- Identify and resolve manufacturing issues in coordination with the CMC team, proactively addressing potential challenges.
- Prioritize and manage studies to focus resources on the most impactful activities.
- Lead and mentor a small team of scientists and associates, providing guidance and leadership to junior members.
- Present research results at scientific conferences, author reports, and contribute to regulatory filings.
- Work cross-functionally with other teams to meet project milestones while maintaining adherence to timelines.
Requirements, Knowledge, Skills and Abilities
PhD in immunology, cancer biology, or engineering science with 0 to 2 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.
Process Development Scientist Pay Rate: $93,000 to $119,500 annually
The final pay 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.
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Career Focus: Analyst, Biology, Immunology
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