| Company: | GenQuest BioScience, Inc. |
|---|---|
| Type: | Full Time |
| City: | Mountain View |
The selected candidate will lead process development efforts and scale-up of the manufacturing process for combination drug delivery / medical device products. You will work closely as part of a team with product design, research and quality groups using principles of concurrent engineering to ensure manufacturability of design. Design and develop processes for manufacturing drug delivery products using statistics based experimentation and principles of process excellence. Work with in-house groups and vendors to ensure regulatory and company compliance of manufacturing processes. Monitor the performance of processes and equipment and make recommendations for continuous improvement. Work with the in-house manufacturing group to scale-up, validate, and transfer the developed process to commercial manufacturing per appropriate guidelines. Generate specifications and develop custom pilot scale and commercial manufacturing equipment along with suitable test methods and process controls. Work with equipment vendors to define, develop, implement and qualify process equipment using recognized industry standards. Conduct investigations in cGMP environment, summarize results in a presentable report format.
Qualifications include B.S. or M.S. in Mechanical, Chemical or Materials Engineering with, 6+ years experience in process and/or equipment development or a Ph.D with 2-5 years direct experience. You should have excellent interpersonal skills to allow effective participation in project teams, be self motivated person with initiative to complete tasks independently. Excellent oral and written communication skills. Good understanding of manufacturing processes – hands-on experience with automated assembly/manufacturing systems in a cGMP environment. Knowledge of PLC programming and associated controls is a plus. Working knowledge of fixtures and test equipment in a manufacturing environment.
Good understanding and use of statistical methods in experiment design and data analysis. Able to analyze complex problems and develop solutions or approaches to resolve. Able to effectively communicate technical results. Able to influence technical decisions. Prior experience with Pharmaceutical / Medical Device process development a plus. Prior experience with automated manufacturing processes a plus.
How to Apply:
Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: jobs@genquestbio.com
To learn more about this position or to preview other opportunities, please visit our website at:
www.genquestbio.com/careers.htm
Qualifications include B.S. or M.S. in Mechanical, Chemical or Materials Engineering with, 6+ years experience in process and/or equipment development or a Ph.D with 2-5 years direct experience. You should have excellent interpersonal skills to allow effective participation in project teams, be self motivated person with initiative to complete tasks independently. Excellent oral and written communication skills. Good understanding of manufacturing processes – hands-on experience with automated assembly/manufacturing systems in a cGMP environment. Knowledge of PLC programming and associated controls is a plus. Working knowledge of fixtures and test equipment in a manufacturing environment.
Good understanding and use of statistical methods in experiment design and data analysis. Able to analyze complex problems and develop solutions or approaches to resolve. Able to effectively communicate technical results. Able to influence technical decisions. Prior experience with Pharmaceutical / Medical Device process development a plus. Prior experience with automated manufacturing processes a plus.
How to Apply:
Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: jobs@genquestbio.com
To learn more about this position or to preview other opportunities, please visit our website at:
www.genquestbio.com/careers.htm
