Description
The Senior Research Associate (SRA) works with the Platform Sciences & Development teams to develop, qualify, and execute safety assay with 51Cr release method for CAR-T product batch release used for early phase clinical trials. The role also covers, but is not limited to, donor screen for the candidate selection to be used for GMP manufacturing campaigns and perform a variety of testing with the techniques of flow cytometry, ddPCR and ELISA to support process development. The Senior Research Associate will adopt a virus titer assay to execute TCID50 method for the confirmation of no detectable Epstein-Barr virus (EBV) in Atara’s final products. This role will also maintain data integrity, capable of effectively communicating the findings and be familiar with the documentation practice required for GMP product release.
Primary Responsibilities
- Owns 1-2 assays as the point of subject matter expert (SME) in the department.
- Executes assay development and method qualification for product lot release and characterization with proper documentations.
- Optimizes the established assays for method improvement.
- Be an integrated team member to collaborate with colleagues within the team and outside of the team.
- Develops and banks proper positive and negative assay control materials.
- Evaluates reagents and supplies to meet QC standard.
- Documents laboratory procedures and experiments with great attention to detail in the required formats.
- Drafts and drives the completion of SOPs, development reports, method qualification protocols, method qualification reports, test methods and the corresponding forms.
- Contributes to laboratory investigations, invalid tests and OOS results, own deviations, if applicable.
- Contributes to Phase 1 testing process refinements, owns Change Control Records for continuous improvement related to the Phase 1 testing system.
Qualifications
- Bachelor’s Degree in a relevant scientific discipline, with 2+ years of relevant experience in development and/or commercial GMP biologics manufacturing environments.
- Fundamental knowledge in analytical methodology and Quality Control.
- Proficient with aseptic cell culture and cell-based bioassays.
- Ability to follow laboratory procedures with attention to detail, and successfully execute experiments on the bench.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Demonstrated ability to maintain detailed lab execution records and perform data analysis.
- Hands-on knowledge of cGMP, Quality Systems, and regulatory requirements for GMP biologics manufacturing, preferably including cell therapy development.
- Demonstrated strong written and verbal communication skills.
- Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
