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