Research Associate I/II or Senior Research Associate I, Analytical Development and Technology

Company: GeneFab
Location: San Francisco
Posted on: March 25, 2025

Job Description:

The Research Associate, Analytical Development and Technology will be a key member of our Technical Development team contributing mainly to analytical testing to support process development. However, participation in analytical method development and new technology evaluation to support the successful development and manufacturing of cell and gene therapy products is also in the scope of this position.The ideal candidate will be highly organized and detail-oriented to ensure timely and high-quality data generation to inform process optimization and decision-making. This role involves close collaboration with process development and analytical development teams to ensure the accuracy and relevance of data.This is a contract role based out of our Alameda, CA facility.Responsibilities: Sample Management and Testing

• Help with implementation of sample management software and procedures for sample receipt, testing tracking, and results release.
• Receive, track, and manage samples from process development from different projects and modalities (cell and gene therapy).
• Perform routine in-process and final product testing on external client and internal development generated materials to support evaluating process performance and product quality.
• Ensure testing is conducted according to established protocols and timelines.Responsibilities: Data Analysis and Reporting
  • Independently analyze experimental data and identify trends or anomalies.
  • Prepare clear, concise, and high-quality data reports for stakeholders.
  • Maintain comprehensive and accurate records of all analyses.
  • Proactively troubleshoot and resolve technical or procedural issues.Responsibilities: Collaboration and Communication
    • Collaborate with process development teams to provide timely results for process development decisions.
    • Collaborate with the Analytical Development team to develop and optimize analytical methods for cell and gene therapy products, including but not limited to assays for product characterization, release testing, and stability studies.
    • Support the preparation of technical reports, documentation, and presentations for both internal and external stakeholders.
    • Participate in cross-functional project teams, working closely with scientists, engineers, and quality assurance professionals.Additional Responsibilities:
      • Maintain and calibrate analytical instruments and equipment, ensuring data accuracy and compliance with regulatory standards.
      • Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
      • Foster a culture of scientific excellence and continuous improvement.Qualifications:
        • Bachelor's or Master's degree in a relevant scientific discipline (e.g., Biochemistry, Chemistry, Molecular Biology).
        • 2 - 5 years of experience in analytical development and testing in the biopharmaceutical or cell and gene therapy field (1 - 3 years with a Master's).
        • Exceptional organizational skills with the ability to manage multiple priorities and deadlines.
        • Strong knowledge of a range of analytical techniques, including but not limited to Flow cytometry, qPCR, ELISA, and cell-based assays. Flow cytometry experience required.
        • Strong attention to detail, problem-solving skills, and the ability to work independently and collaboratively.
        • Familiarity with regulatory guidelines (e.g., FDA, EMA) and GMP/GLP requirements is advantageous.Compensation: $40 - $57 an hourAbout GeneFabGeneFab 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.
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Keywords: GeneFab, San Francisco , Research Associate I/II or Senior Research Associate I, Analytical Development and Technology, IT / Software / Systems , San Francisco, California