Add

Engineer II

Responsibilities:
-Facilitate cell culture process transfers to contract and Genentech-partner manufacturing facilities.  Includes authoring and
reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing.
-Lead and participate in cross-site MSAT teams responsible for developing global standards and best-practices, troubleshooting multi-
site issues, and analyzing cross-site process performance data.
-Represent MSAT Network on corporate initiatives led by other groups such as Quality, Regulatory, Manufacturing Operations, Process Research and Development, etc.
-Provide ongoing technical support for processes currently being manufactured at contract and partner manufacturing sites.  Includes support of discrepancies, investigations, and change
control; process data review; and representation of external sites on Genentech Process Technical Teams.
-Some lab work will be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
Travel to Contract and Genentech partner manufacturing sites will be required and may be up to 25% of your time.

Requirements:
-BS/MS/PhD. in Chemical/Biochemical Engineering
-At least 3-5 years relevant industrial experience in cell culture and/or E. coli support of manufacturing operations or process
development.  
-Candidate should have a sound background in large-scale processing and engineering fundamentals as applied to cell culture.  
-Experience with transferring processes and/or with process validation is a plus.
-Candidate must be highly motivated and able to work independently as well as in teams.
-Excellent organizational and communication skills required (both written and verbal).  
-Experience leading teams also a plus.


DIVISION:  Process Dev & New Manuf Facil
REQUISITION NUMBER:  09-1000029643