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Associate Director Vector Analytical Development

Company: Atara Biotherapeutics, Inc.
Location: Denver
Posted on: February 22, 2021

Job Description:

Associate Director, Vector Analytical Development The Associate Director Vector Analytical Development will have overall responsibility for leading and managing a dynamic team developing advanced analytics supporting viral vector characterization and release. The ideal candidate will assume a key leadership role in the development of analytical strategies and will be expected to implement on platform evaluation, deep characterization of viral vectors (adenovirus, retrovirus), CQA assessments, etc. in early-stage clinical manufacturing, product release testing, and product characterization. The individual with work to build, manage, and mentor a strong technical team to deliver key data, documentation, and knowledge transfer. Primary Responsibilities:

  • Oversee the development, optimization, and qualification/validation of robust molecular and cellular assays:
  • NGS, qPCR, ddPCR and other molecular assay platforms for the characterization of cell and gene therapy drug products, vector, and critical starting material
  • Evaluation of nucleic acid characteristics like residual impurity DNA, residual adeno- and retrovirus, etc.
  • Cell-based functional assays for viral transduction/gene expression
  • Provide expertise for enhancing existing assays, and implementation of new ideas and technologies
  • Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
  • Represent the analytical development team in cross-functional CMC meetings, and actively participate in strategy design, execution, data presentation and follow-up.
  • Form active collaboration with other teams within Analytical Development, Process development, Research and Quality teams.
  • Collaborate with external partners, CMOs to lead or monitor outsourcing activities, manage timelines, and ensure deliverables.
  • Author technical reports, protocols, and analytical sections of regulatory filings. Qualifications Education, Experience and Skills

    • MS/Ph.D. in virology, molecular biology, or related sciences such as cell biology, genetics, or immunology
    • Minimum 8 years (Ph.D.) or 15 years (MS) of biopharma industry experience with demonstrated track record of successfully developing different molecular biology analytical methods using techniques like next-generation sequencing (NGS) platforms, qPCR, droplet digital PCR (ddPCR), flow cytometry

    • Deep understanding in advanced analytical platforms and method development/qualification/validation of CAGT methods including cell-based assays, cytotox assays, flow cytometry and/or single cell molecular assays
    • Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate GMP requirements is required.
    • Prior experience of IND, BLA or equivalent regulatory filings is highly preferred.
    • Experiences with analytical or statistical software (e.g., JMP, Softmax Pro, Gen5 etc.), is highly desirable.
    • Experience of working with and managing external vendors/ CROs is preferred.
    • Experience working with automation of analytics is preferred
    • Strong writing, reviewing, and presentation skills is required.
    • Must have strong organization skills, and experience of mentoring Ph.D.-level scientists is required.
    • Ability to multi-task in a fast-paced environment with changing priorities. More About Atara Bio We launched--Atara Biotherapeutics--in August 2012 to help patients with serious diseases and few therapeutic options. We're named after Atara Ciechanover who suffered from cancer before passing away. 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 400+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.

      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." Visit www.atarabio.com 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. Thousand Oaks, California Associate Director, Vector Analytical Development

Keywords: Atara Biotherapeutics, Inc., Denver , Associate Director Vector Analytical Development, Executive , Denver, Colorado

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