Associate Scientist, Process Development

AstraZeneca is seeking a highly motivated researcher to join the Process Development team, as Associate Scientist, supporting and contributing to the design and execution of studies to develop and optimize clinical manufacturing processes of AstraZeneca’s portfolio of engineered T cell therapies. 

As a member of the Process Development team, this role will also support technology transfer to the clinical production site. Based in Santa Monica, CA, this role reports to the Senior Scientist, Process Development.  

Essential Functions and Responsibilities  

• Support experimental design and execute experiments to develop and optimize manufacturing processes for genome-engineered T cell products. 

• Collect and analyze experimental data and present findings in team meetings. Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design. 

• Provide support across different process development areas during high-volume activities. Prepare critical process materials including formulation of media and ribonucleic protein complexes. 

• Assist with process development and tech transfer of GMP manufacturing processes to internal and external manufacturing organizations. 

• Stay current with scientific advancements and emerging technologies in cell therapy process development. Help evaluate new technologies and methodologies to enhance process efficiency. 

• Maintain accurate and detailed laboratory notebooks and electronic records in compliance with company policies and regulatory requirements.  

• Assist in preparing technical documents, including standard operating procedures (SOPs), batch records, and development reports, as needed.  

• Work effectively in a team environment to meet project timeline and objectives.  

• Perform other duties as assigned. Position may require weekend work. 

Required Skills 

• Hands-on experience with the development of engineered TCR T cell therapies. 

• Hands-on experience with genome editing tools including DNA/RNA transfection approaches. 

• Familiar with process development for cell therapies, including scale-up and interpretation of T-cell functional assay results (flow-cytometry, cytotoxicity, proliferation). 

• Experience with authoring manufacturing batch records. 

• Strong organizational and time management skills. 

• Excellent teamwork and communication skills, with the ability to work collaboratively cross-functionally.  

• Proficiency with Microsoft Office, including Word, Excel, Outlook and PowerPoint. 

Desired Skills 

• Knowledge of cGMP manufacturing and practical experience in GMP operations.  

• Experience with statistical analysis software (e.g. JMP, GraphPad Prism) for analyzing and presenting data. 

• Familiar with the fundamentals of the Design of Experiments approach. 

Education 

• BS or MS degree in Biology, Biotechnology, Biomedical Engineering, or related field with 1+ years of experience for MS or 2+ years of experience with BS