Scientist/Sr. Scientist - Analytical Development

Job Locations US-CA-Thousand Oaks
ID
2020-1312
Category
Process Sciences
Type
Regular Full-Time

Job Description

The Scientist/Sr Scientist will work with the Analytical Development team to develop and implement analytical methods to characterize T cell therapy manufacturing processes and products across the Atara EBV T-cell platform, with an emphasis on flow cytometric methods for characterization and lot release.  The candidate will be expected to design and perform experiments and, organize, document, analyze and interpret results with a high degree of independence and leveraging sound scientific principles. The candidate will serve as a flow subject matter expert on cross-functional teams, and thus strong written and verbal communication is essential.  Experience writing and reviewing GMP documentation including SOPs, reports, risk assessments, etc. will be critical for success.

 

Primary Responsibilities:

  • Establishes, characterizes, optimizes and qualifies assays for characterization and lot release testing of T-cell therapy products
  • Manages design and execution of flow cytometry assay development and method qualification work
  • Characterizes cell therapy starting materials, process intermediates and products; recommends specifications and provides supporting rationale
  • Supervises lab-based staff and executes experiments; independently performs detailed analysis of data and interprets results; applies conclusions to thoughtful proposals for follow-on work
  • Authors test-method SOPs, method development reports, qualification protocols, risk assessments and transfers methods to partner functions, as needed
  • Represent Analytical Development as a flow cytometry SME in collaboration with other functions (Translation Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, etc) at Atara and external partners
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Qualifications

Qualifications:

 

Required

  •  PhD in a biomedical/biological sciences with 3+ years of industry related experience or Master’s Degree with 7+ years of related industry experience or Bachelor’s Degree with 10+ years of related industry experience
  • Knowledge and experience in bioassays, immunoassays, flow cytometry, mammalian cell culture, molecular biology
  • Deep knowledge in immunology and/or cell biology, hands-on experience in analytical development, method qualification, validation and transfer
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Basic understanding of GLP, GDP and GMP requirements

 

Preferred

  • Analytical Development experience with cell and/or gene therapy
  • Familiarity with development of cell-based therapeutics supporting early and late trials
  • Working familiarity with statistical analysis tools and methods including Design of Experiment (DOE) studies

 

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 350+ 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.
 
 

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