Scientist, Process Development

Location: Santa Monica, CA

Duration: 12 months

Pay: $48-$51 per hour

Title: Scientist, Process Development 

Position Summary: 

Astra Zeneca is seeking a motivated Scientist with expertise in cell therapy to join our Process Development team. This laboratory-based role will support development of clinical manufacturing CART and TCR processes. The Scientist will be responsible for evaluation of technology and process improvements and play a key role in process understanding and process characterization. Additionally, the process engineer will be involved in manufacturing support and technology transfer to ensure successful implementation in a cGMP environment. The successful candidate will have knowledge of basic engineering principles, bioprocess development, and cGMP manufacturing. 

Essential Functions and Responsibilities:

• Process Development: Aid in the design, development, optimization, and characterization of cell therapy manufacturing processes by leading projects and workstreams. 
• Perform cell culture of T cells in multiple formats including flasks, bags, and bioreactors. 
• Define appropriate studies regarding process investigations as required to support manufacturing activities and regulatory filings. 
• Prepare and review experimental proposals, technical reports, SOPs, and manufacturing batch records. 
• Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design. 
• Aid in the identification of new bioprocessing technologies and their implementation in cGMP manufacturing processes. 
• Perform other duties and special projects as assigned.  

Required Skills/Abilities: 

• Experience in technical development of cell and gene therapy or biologics in early and late stage development setting. 
• Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.
• Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations. 
• Knowledge of QbD, DOE and statistical analysis tools (e.g. JMP, MiniTab). 
• Ability to think critically, analytically and have demonstrated troubleshooting and problem- solving skills based on deductive reasoning. 
• Strong verbal and written communication skills, including technical writing. 

Education and Experience: 

• MS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 2+ years relevant industry experience or BS degree with 4+ years relevant industry experience or 8+ years relevant industry experience. 

Physical Requirements: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: • Sit and talk or hear. • The employee frequently is required to use hands to finger, handle, or feel. • The employee is occasionally required to stand, walk, and reach with hands and arms. • The employee must occasionally lift and/or move up to 10 pounds. • Specific vision abilities required by this job include close vision and ability to adjust focus in order to read. • The noise level in the work environment is usually moderate. • This position requires working with biological and/or chemical hazards