Scientist, Analytical Development
Company: Tenaya Therapeutics
Location: San Francisco
Posted on: June 26, 2022
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
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.
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.
- 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
- 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
- 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
- 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).
- 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
- 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
- Experience with analysis of gene therapy viral vectors is
- Experience in developing release assays or additional
characterization assays for a biotechnology company is highly
- 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
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
Keywords: Tenaya Therapeutics, San Francisco , Scientist, Analytical Development, Other , San Francisco, California
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