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VP, Viral Vector

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Job Description

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 products.

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%)

Primary Responsibilities

  • 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 timelines
  • Shapes approach, strategy and policies for vector developing functions.
  • 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 teams.
  • Hires, supervises and mentors scientific staff.

Qualifications

  • Advanced degree in a biological science, preferable a PhD in virology, with 15+ years of relevant experience in late-stage product development.
  • Fundamental knowledge in virology, molecular biology, cell culture, virus purification techniques and assays standard to viral vector characterization
  • 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 excellence."

Our vision - "T-Cell Immunotherapy for every patient, any time."

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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