Scientist - Biotech Engineering

Scientist - Biotech Engineering

A Scientist would be expected to act as a lead technical support for a pre-commercial drug product program within process development to achieve the resolution of technical issues, to author technical documents and support all technical issues around commercialization of the drug product. Support of technology transfer and site selection, equipment selection, process design, validation strategy, and relevant GMP documentation is also required.
The scientist applies fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve processing issues and develop a robust commercial product, as well as evaluating changes such as process improvements, equipment, scale, and raw materials Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and
regulatory filings. Travel will be required.

Basic Qualifications
• Doctorate degree
OR
• Master's degree & 3 years of directly related experience
OR
• Bachelor's degree & 5 years of directly related experience
OR
• Associate's degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications
Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or Life Sciences. 4+ years of relevant biotech experience in process development within a pharmaceutical or biotechnology corporation.
Ability to apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to develop the drug product process, troubleshoot manufacturing operations, evaluate equipment design, and scale up the drug product process.
Experience with process development for biologics including lyophilization cycle development.
Experience participating in global, cross-functional teams working on technology transfer of biologics.