Scientist (Analytical Development, Cell Therapy)

AstraZenecaGaithersburg, MD
Hybrid

About The Position

Join our Cell Therapy Analytical Development team, where we develop and deliver robust, technologically advanced biological assays to progress cell therapy products from research to commercial stages. Our team supports the end-to-end biological and bioanalytical characterization of viral vector and cell therapy products, enabling manufacturing processes, formulation, drug development, and regulatory filings from IND to BLA and beyond. We collaborate closely with analytical quality and several cross-functional teams, including clinical, regulatory, QA, and manufacturing.

Requirements

  • Bachelor’s degree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with 5 + years of relevant experience or a Master's degree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with 3 + years of relevant experience.
  • Biotechnology or pharmaceutical industry experience working with analytical for lentiviral vector and CAR T cells.
  • Experience method qualification/validation and tech transfer of cell and gene therapy analytical methods.
  • Highly proficient in immunology techniques, such as ELISA or similar technology platforms.
  • Highly proficient in molecular biology techniques, such as qPCR, dPCR, for gene edit evaluation, on target /off target analysis.
  • Excellent written and oral communication skills.
  • Good time management and organizational skills with the ability to prioritize tasks from multiple projects to meet timelines.

Nice To Haves

  • Experience in biophysical analysis such as DLS, HPLC, mass spectrometry and capillary electrophoresis.
  • Flow virometry is a plus for lentiviral vector characterization.
  • Experience with NGS is a plus.

Responsibilities

  • Develop robust functional, characterization, and molecular analytical methods including method qualification and transfer.
  • Make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experiments independently.
  • Carry out analytical development/ sample testing to enable lentiviral vector upstream and downstream process development.
  • Author/ review technical reports, protocols, and technical summaries for presentation.
  • Present and discuss experimental results at group/project team meetings.
  • Work in a team-based structure and interface with research and process development departments.

Benefits

  • Qualified retirement programs
  • Paid time off (i.e., vacation, holiday, and leaves)
  • Health coverage
  • Dental coverage
  • Vision coverage
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