Proclinical is currently recruiting for a Process Engineer with a biopharmaceutical company located in Santa Monica, CA. As a Process Engineer, you will provide process development and engineering support for process design and development, process characterization, and leading process improvements in GMP manufacturing.
- Lead/execute laboratory studies to support process design and development, characterization and process improvements
- Contribute to the development of stability-indicating assays
- Design/execute developmental stability studies by employing a variety of biochemical and biophysical analytical techniques
- Participate and report to a cross-functional development team to advance production activities
- Develop manufacturing processes to enable cell therapy products and develop process improvements and efficiencies
- Perform process analysis and trend process performance
- Planning/execution of viral vector fill/finish development activities encompassing early and late stage development
- Screening, optimization, and scale-up of sterile filtration, agitation, filling, freezing and thawing unit operations.
- Assist in technology transfer to GMP manufacturing
- Support scale down model development and process characterization activities.
- Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
Skills and Requirements:
- BS/MS Degree in Pharmaceutical Sciences, Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology or a related discipline.
- 5+ years of industry experience in related field.
- Knowledge of cGMP manufacturing and regulatory regulations
- Experience in statistical analysis using JMP or Minitab
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Process validation experience in a cGMP environment is a plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Claudia Reid at 215-531-5315 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.