VP, Viral Vector
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
The VP, Viral Vector Operations leads process and analytical
development functions and staff in support of product and platform
development for Atara's allogeneic and autologous T-cell
The VP will assure late-stage vector reagent processes are
characterized and optimized, and lot release and characterization
assays are validated in compliance with FDA regulations and other
jurisdictions. The VP will author and/or review method sections of
CMC regulatory submissions and represent the viral vector technical
functions in regulatory interactions. The role requires breadth of
experience across cell line construction, process development and
analytical development for GMP-manufactured viral vectors and a
history of regulatory interactions. The successful candidate must
have successfully demonstrated leadership, technical proficiency,
scientific creativity and collaboration with others.
Reports to: Head of GMP Quality and Process Sciences
Location: Thousand Oaks, CA
Travel: Travel required (up to 20%)
- Serves as the technical and strategic expert in producer cell
line construction, virus production and purification process
development and virus characterization method development for
quantifying strength, purity and potency attributes.
- Establishes, communicates and manages project plans and
- Shapes approach, strategy and policies for vector developing
- Provides technical and compliance guidance to cross-functional
teams regarding viral vector considerations.
- Represents the viral vector function for authoring, reviewing
and/or approval of GMP and regulatory documents as appropriate,
including SOPs, protocols, reports, specifications, QTPPs, risk and
impact assessment, and filing sections.
- Collaborates with Atara T-cell Process Development,
Manufacturing, Quality and Regulatory functions as well as with
functional leads of external partners to maintain alignment of
goals and to navigate project obstacles.
- Strategizes and leads/supervises communications with regulatory
agencies regarding vial vector subject matter.
- Leads project sub-teams and working groups and may serve as
Technical Project Lead representing Technical Operations on product
- Hires, supervises and mentors scientific staff.
- Advanced degree in a biological science, preferable a PhD in
virology, with 15+ years of relevant experience in late-stage
- Fundamental knowledge in virology, molecular biology, cell
culture, virus purification techniques and assays standard to viral
- Breadth of knowledge across viral vector development, cGMP,
Quality Systems and regulatory requirements for cell and viral
banks and viral vector parenterals or cell therapy reagents.
- Demonstrated in-depth skills in designing, executing,
interpreting and documenting experiments.
- Experience authoring CMC sections of regulatory documents.
- Supervisory experience
- Demonstration of strong communication skills, leadership skills
and ability to effectively influence others.
- Role model for Atara TRAIT values (Transparency, Respect,
Accountability, Integrity, Trust)
More about Atara Bio
We launched Atara Biotherapeutics in August 2012 to help
patients with serious diseases and few therapeutic options. We are
considered a leading off-the-shelf T-cell immunotherapy company
(Nasdaq ATRA) developing novel treatments for patients with cancer,
autoimmune and viral diseases.
We're proud of our team of 425+ Atarians co-located by design in
4 different locations including South San Francisco (corporate
headquarters), Thousand Oaks (R&D and manufacturing
headquarters), Zug, Switzerland (european headquarters) and a
R&D site in the Denver, Colorado area. Our Southern California
hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara
T-Cell Operations and Manufacturing (ATOM) facility. Our mission -
"Transform the lives of patients with serious medical conditions
through pioneering science, teamwork, and a commitment to
Our vision - "T-Cell Immunotherapy for every patient, any
Atara offers a competitive benefits packages that includes
medical/dental/vision benefits, life and disability, retirement and
stock program, as well as a generous paid time off and wellness
plan that supports the well-being of our staff. Visit
www.atarabio.com/careers to learn more.
Atara Bio is an equal opportunity employer and makes employment
decisions on the basis of merit and other lawful factors. In
accordance with applicable law, the Company prohibits
discrimination based on race, color, religion, creed, sex, gender
(including pregnancy, childbirth or medical condition related to
pregnancy or childbirth), gender identity, expression or dysphoria,
marital status, age, national origin or ancestry, physical or
mental disability, medical condition, genetic information, veteran
status, caregiver status, sexual orientation, transgender status or
any other classification protected by federal, state or local laws
or because of the individual's association with a member of a
protected group or connection to an organization or group related
to a protected group.We comply with all applicable national, state
and local laws governing nondiscrimination in employment as well as
employment eligibility verification requirements of the Immigration
and Nationality Act. All applicants must have authorization to work
for Atara Bio in the United States.
Keywords: Atara Biotherapeutics, Thousand Oaks , VP, Viral Vector, Other , Thousand Oaks, California
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