ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Sr. Director, Analytical Development

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

Job Description:

Job Description

The Sr. Director, Analytical Development leads the analytical development function and staff in support of product and platform development for Atara allogeneic T-cell therapies. Responsibilities include establishing and managing work plans to achieve goals for analytical method development across all T-cell therapy products, including application of methods to stability and comparability protocols. The Sr. Director will assure lot release and characterization assays are developed and implemented in compliance with FDA regulations and other jurisdictions and will assure appropriate method qualification and transfer to QC, and support validation. The Sr. Director will author and/or review method sections of CMC regulatory submissions and communications and represent the analytical function in regulatory interactions. The role requires breadth of experience across analytical functions and a history of regulatory interactions regarding parenteral product development. Importantly, the Sr. Director will have experience developing assays to quantify strength, purity and potency of cell therapy products, preferably engineered T cells. The successful candidate must have successfully demonstrated leadership, technical proficiency, scientific creativity, initiative and collaboration with others.

Reports to: VP, Process Sciences

Location: Thousand Oaks, CA

Travel: up to 25%

Primary Responsibilities

  • Serves as the technical and strategic expert in method development for strength, purity and potency attributes of T-cell therapy products for purposes of product lot release and characterization in association with a GMP manufacturing environment.
  • Establishes, communicates and manages project plans and timelines for phase-appropriate method development, qualification, transfer to QC and validation support.
  • Responsible for execution of Phase 1 product release testing per qualified methods within a phase-appropriate GMP-compliant testing operation.
  • Shapes approach and policies for developing and establishing analytical methods.
  • Provides technical and GMP compliance guidance to cross-functional teams in support of project goals.
  • Represents the analytical development function for authoring, reviewing and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, CQAs, risk and impact assessment, and filing sections.
  • Collaborates with Atara 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 analytical 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 with 15+ years of relevant experience in biologics development including cell therapy development and late-stage product development (PhD preferred).
  • Fundamental knowledge in cell biology, immunology, cell culture, cell-based assays and assays standard to cell therapy product characterization.
  • Breadth of knowledge across analytical method development, method validation, cGMP, Quality Systems and regulatory requirements for biologics including cell therapies.
  • Demonstrated in-depth skills in designing, executing, interpreting and documenting experiments.
  • Experience authoring methods and characterization sections of CMC 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 , Sr. Director, Analytical Development, Other , Thousand Oaks, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Thousand Oaks RSS job feeds