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Scientist II, Downstream Viral Vector Process Development

Posted 15 days ago

genefabAlameda (CA)

SENIORITY

Lead

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About the role

GeneFab Job Opportunity GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies. We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
About the Role: GeneFab is seeking an experienced Downstream Process Development Scientist/Lead focused on viral vector purification (AAV and Lentiviral) for in vivo gene therapy. It is a technical, project-based role within a CRDMO environment that balances hands-on process optimization with cross-functional leadership and client-facing responsibilities.
What You'll Do:
  • Design, optimize, and scale-up downstream processes for the purification of viral vectors, with a focus on in vivo gene therapy products and lentiviral vectors.
  • Execute experimental plans, analyze data, and provide insightful recommendations to improve process efficiency, yield, and product quality.
  • Collaborate with cross-functional teams, including Upstream Process Development, Analytical Development, and Manufacturing, to ensure seamless integration of processes.
  • Troubleshoot and resolve technical challenges in downstream processes, ensuring robust and scalable solutions.
  • Present internally and to client with project status updates
  • Stay abreast of industry trends, emerging technologies, and regulatory guidelines to contribute to the continuous improvement of processes and compliance.
  • Provide direction and leadership to development associates as the team expands.
Qualifications: Ph. D. or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with a minimum of 3 years (Ph.D.) or 5 years (Master's) of relevant industry experience Proven expertise in downstream process development for viral vectors, with a focus on AAV and lentiviral vectors. Hands-on experience with chromatography, filtration, TFF and other downstream processing techniques. Strong analytical and problem-solving skills, with the ability to interpret complex data sets. Excellent communication skills and the ability to work collaboratively in a team environment. Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing. Experience with formulation science preferred

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