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Scientist, Analytical Development

Company: Tenaya Therapeutics
Location: San Francisco
Posted on: June 26, 2022

Job Description:

Description

Tenaya Therapeutics is a publicly held biotechnology company committed to a bold mission: to discover, design, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and University of Texas Southwestern Medical Center (UTSW), we are advancing a deep and diverse pipeline that includes both gene therapies and small molecules.

Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 110 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak - the delivery of new therapies for heart disease to the patients who need them.

For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.

Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.

Requirements

We are seeking a motivated and knowledgeable scientist to join our CMC Analytical Development team and focus on the development of relevant purity, strength, potency and identity assays for gene therapy viral vectors. Development of assays for other therapeutic modalities may be added later. This position, reporting to the Exec Director of Analytical Development, will be responsible for the development, qualification and transfer of release and stability assays for Tenaya's clinical pipeline, with an initial focus on gene therapies for cardiomyopathies. Your responsibilities may also include leadership of the assay development effort for one or more preclinical pipeline programs. You will be part of a dynamic, small company environment dedicated to finding new, cutting-edge therapies for heart disease.

Job Description:

  • Develop and optimize assays to assess the purity, potency, strength, and identity of gene therapy viral vectors. Assays may include vector genome titer and capsid titer assays; residual impurity assays using ddPCR, qPCR, ELISA, or Western methods; cell-based potency assays (infectivity, transgene RNA or protein expression, functional assays); Sanger or next-gen sequencing; and other chromatographic, electrophoretic or spectrophotometric methods.
  • Qualify assays for release testing and transfer the methods to internal Quality Control or external contract testing laboratories. Assist testing labs in troubleshooting the methods as appropriate.
  • Oversee assay development, optimization, and testing efforts at contract testing labs.
  • Perform these assays on process and/or product-related samples in support of process development & optimization, characterization, scale-up, and comparability studies.
  • Represent the AD group at project core teams and inform/plan/execute the analytical development activities for applicable programs. Assume responsibility for progress towards assay development goals.
  • Manage one or more Research Associates. This will include task assignments, budgeting, performance reviews, and mentoring.
  • Bring in appropriate new technologies for assay improvements.
  • Design and perform special studies involving formulation development, device compatibility and other topics as needed.
  • Write, review and revise assay-relevant sections of CMC regulatory submissions (Characterization, Impurities, Control of Drug Substance /Drug Product).

    REQUIRED KNOWLEDGE/EXPERIENCE:
    • In-depth knowledge and experience in several applicable analytical techniques, including cell-based and/or flow cytometry-based assays, DNA detection by qPCR/ddPCR, SDS PAGE / capillary electrophoresis; Western blot analysis, ELISA, UPLC, Sanger or next-gen sequencing.
    • Excellent oral and written communication skills, including the ability to concisely present results and conclusions at project team and department meetings.
    • Knowledge of general cellular and molecular biology laboratory techniques.
    • Ability to trouble-shoot analytical methods and equipment
    • The ability to work in a fast-paced team environment and to meet challenging deadlines under pressure.
    • Education: MSc or Ph.D. in a Life Sciences or Biotechnology-related subject (or equivalent). BS acceptable with extensive relevant experience (5 years or greater) in gene therapy assay development.

      PREFERRED KNOWLEDGE/EXPERIENCE:
      • Experience with analysis of gene therapy viral vectors is highly preferred.
      • Experience in developing release assays or additional characterization assays for a biotechnology company is highly preferred.
      • Good understanding of bioprocess development and the manufacture of biopharmaceuticals would be advantageous.
      • Experience designing, executing, analyzing, and summarizing experiments for assay verification, qualification, and validation reports for the CMC/CTD sections of regulatory filings is preferred.

        Benefits

        We offer a dynamic start-up environment, and a collaborative, passionate team focused on a compelling vision and mission. We offer competitive salaries and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time, and holidays. State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym. Shuttle service to/from Caltrain, BART, and the South San Francisco Ferry. Tenaya is proud to be an equal-opportunity workplace.

Keywords: Tenaya Therapeutics, San Francisco , Scientist, Analytical Development, Other , San Francisco, California

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