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EPM Scientific - South San Francisco, CA
posted 2 months ago
About the position
The Downstream Process Development Scientist specializing in AAV Gene Therapy is responsible for developing and optimizing downstream purification processes for adeno-associated virus (AAV) vectors used in gene therapy. This role involves working with viral vector purification technologies, designing scalable and robust processes, and ensuring high purity and quality standards for clinical and commercial production. The scientist will collaborate with cross-functional teams to deliver high-quality gene therapy products that support therapeutic needs.
Responsibilities
- Design and execute experiments to improve process scalability, robustness, and reproducibility.
- Implement new technologies and approaches to streamline purification workflows and improve productivity.
- Collaborate with upstream development, analytical, and manufacturing teams to ensure seamless process integration.
- Develop, optimize, and scale downstream purification processes specific to AAV vectors, utilizing techniques such as chromatography, filtration, and ultracentrifugation.
- Design and execute experiments to enhance the yield, purity, and quality of AAV vectors, ensuring process reproducibility and scalability.
- Evaluate and implement new technologies to streamline AAV purification workflows and improve process efficiency.
- Lead the transfer of optimized AAV purification processes to GMP manufacturing, including support for scale-up and troubleshooting.
- Provide technical support for pilot-scale and commercial manufacturing campaigns, including training and guidance for manufacturing personnel.
Requirements
- Ph.D. or Master's degree in Biochemistry, Chemical Engineering, Biotechnology, or related field, with 2+ years of relevant industry experience (or equivalent experience for those with a Ph.D.).
- Strong background in AAV purification and downstream process development, including chromatography (affinity, ion exchange, size exclusion), filtration, and other separation techniques for viral vectors.
- Proficiency in analytical techniques such as HPLC, SDS-PAGE, ELISA, and spectroscopy.
- Strong problem-solving skills with the ability to troubleshoot complex purification challenges.
- Proficiency in analytical techniques such as qPCR, HPLC, ELISA, DLS, and ddPCR for AAV characterization.
- Experience with design of experiments (DOE) and statistical analysis tools (e.g., JMP).
- Prior experience in process validation and technology transfer for gene therapy or viral vector production.
- Excellent communication skills for cross-functional collaboration and technical reporting.
Benefits
- Opportunity to work with cutting-edge technologies in biopharmaceutical development.
- Collaborative work environment with opportunities for professional growth.
- Comprehensive benefits, including health insurance, retirement plans, and educational assistance.
