Associate Scientist, Process Development

Associate Scientist, Process Development

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases.

Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

Position Summary

We are seeking a researcher to join the Process Development team as Associate Scientist, contributing to the design and execution of studies to develop and optimize clinical manufacturing processes of our portfolio of engineered T cell therapies.

Based in Santa Monica, CA, you will report to the Senior Scientist, Process Development.

Responsibilities

• Design and execute experiments to develop and optimize robust and scalable manufacturing processes for manufacture of genome engineered T cell products.
• Conduct detailed characterization studies to understand process and product quality attributes for cell therapy drug product manufacturing.
• Collect and analyze experimental data and create concise reports summarizing findings and recommendations. Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
• Collaborate with cross-functional teams, including research / development scientists, manufacturing personnel, and quality control, to ensure seamless technology transfer from process development to manufacturing.

Communicate project updates, results, and strategies to stakeholders and team members.

• Stay up to date with the latest scientific advancements and emerging technologies in cell therapy process development. Help implement new technologies and methodologies to enhance process efficiency and productivity.
• Maintain accurate and detailed laboratory notebooks and electronic records in compliance with company policies and regulatory requirements.

Prepare and review technical documents, including standard operating procedures (SOPs), batch records, and development reports.

Work in a team environment to meet project timelines and goals.

Supervisory Responsibilities

Junior associates (as assigned)

Education and Experience

• At least 3 years of demonstrated hands-on experience developing production processes for genome engineered primary cells (required) including T cells (preferred).
• At least three (3) years practical experience with Flow Cytometry.
• Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products.
• Proficiency with Excel or statistical analysis software (JMP, Minitab, Prism, etc.) for analyzing and presenting data.
• Understanding of US / EU regulatory requirements and working knowledge of cGMPs.
• Ability to think critically, analytically, and have demonstrated troubleshooting skills based on deductive reasoning.
• Minimum of a BS degree in Immunology, Cell Biology, Molecular Biology, Bioengineering or related discipline with 5+ years relevant experience or MS degree with 3+ years' experience.
• Relevant experience within pharmaceutical or biotech industries in cell therapy preferred.

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