Dana S.
PRODUCT MANAGER - Drug Product Technical Leader
- Role
- Quality Professional and Product Management at Genentech
- Location
- Beaverton, OR, US
- LinkedIn followers
- 500 followers
About Dana S.
Specialties: Quality Assurance, Quality Control, Qualification, Validation…
Experience
Quality Professional and Product Management
Nov 2006 — Present · OR, US
PRODUCT MANAGER - TECHNICAL PROFESSIONAL RolePRODUCT MANAGER, Drug Product Technical Leader(gBMSAT/PTDB/PTIB/PTIP/PTTJ). June 2014 - PRESENTDrug Product Lead / Owner - Various Commercial and Late Stage Development products across the entire product lifecycle.QUALITY PROFESSIONAL RolesSenior Principle, Quality Reliability March 2013 - June 2014Hillsboro, OregonDirector of Quality Assurance Nov 2006-March 2013Hillsboro, OregonLeadership accountability: Manufacturing Quality Assurance organization supporting end to end daily operations including Incoming Warehouse, Formulation, Aseptic Filling, Inspection and Packaging.QA Validation organization supporting end to end lifecycle leadership from conceptual design thru commissioning, IQ/OQ/PQ, Cleaning Validation, Process Validation and routine Periodic Monitoring/ReQual/ReVal.2006 thru 2012 Green-Field Expansion in Hillsboro, OR: Accountable for Site Quality Assurance, QAV and Validation supporting capital project in Hillsboro Oregon. Facility licensed in three phases with final phase licensed Aug 2012.
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