Process Development Specialist

Proclinical is currently recruiting for a Process Development Specialist with a pharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

• Execute laboratory studies in order to support process development or improvements
• Perform hands-on work in a cell culture lab, specifically cell culture expansion, viral vector production as well as process scale-up and implementation into GMP clinical production suites
• Write and review technical documentation
• Perform process analysis and trend process performance
• Design and execute process development studies to develop a thorough understanding of operating and performance parameters
• Contribute to the development and scale-up of the viral vector production with a focus on viral vector cell line and cell culture development including lead clone selection, process optimization, scale-down model development and qualification, robustness studies, and process characterization
• Support development of upstream technology platforms to integrate process, media and cell line development

Skills and Requirements:

• BS/ MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
• Previous experience with both adherent and suspension cell culture systems, transient transfection and/or stable cell lines is desired
• A previous track record of culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents
• Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with automation technologies is desired
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Excellent interpersonal, verbal and written communication skills are essential
• Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
• Ability to work and collaborate in cross-functional teams, research, development, manufacturing in a fast pace and dynamic team setting
• High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Knowledge of cell culture scale-up and engineering principles (e.g. growth rates, specific consumption/production rates, bioreactor aspect ratios, power calculations, gas transfer, shear stress)
• Knowledge of statistical DOE (design of experiments)
• Build, operate, and troubleshoot benchtop and pilot-scale bioreactors; compile and analyze results
• Excellent communication and presentation skills and aptitude for problem-solving
• Candidate should be self-motivated, ambitious, organized, and collaborative

If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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