Process Development / Tech Transfer Associate Engineer (USP)
ND Reference : JDSG201700.000.01PDE
The Associate Engineer will be responsible for supporting technology transfer and ongoing commercial operations. Will apply process engineering knowledge to support development, scale-up and technology transfer of commercial protein biologics processes. Scope of work could include:
- Collect data from electronic systems for use in Process Development reports and regulatory filings. Data verify their work as well as the work of others to enable transfer of processes and process improvements from remote sites into manufacturing facilities
- Provide on-the-floor technical support for successful scale-up / technology transfer / troubleshooting issues, including sample coordination and data collection
- Experience in data collection from electronic systems in accordance with GMPs
- Participates in team efforts directed at solving issues and advancing development/technology programs
- Authors technical reports
- Gives effective presentations within the department
- The candidate will work in a team environment, collaborating with various colleagues in process development.
- At least 5 – 7 years’ relevant experience working specifically in the pharmaceutical industry
- A Degree in Engineering or Science disciplines
- Experience in supporting cGMP cell culture, recovery, chromatography, and/or filtration at the commercial scale. This includes technical support for nonconformance investigations and other commercial support activities.
- Experience in transferring cell culture and/or purification processes at the commercial scale
- Experience in advanced statistical approaches
- Experience with the use of analytical instruments and interpreting the scientific data based upon these techniques