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Karen Grinker
Principal Technical Manager, Device and Packaging Development @Genentech
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WORK HISTORY
Principal Technical Manager, Device and Packaging Development @Genentech
South San Francisco, CA, US
Device Team Leader for ocular PFS -Leads cross-functional teams to complete development and commercialization. Includes meeting key milestones, identifying and mitigating potential risks, risk communication to stakeholders, and ensuring filing timelines are met.SSF Lead for a Digital Transformation project-Successfully validated and deployed Siemens Polarion ALM software to manage device development requirements and risks-Utilized AGILE project management methodology to work with Siemens consultants and Roche IT to create and prioritize user stories which are implemented in a series of sprints- Currently squad leader which focuses on continuous improvement of design control processes executed with the software.Device Team Product Care Leader for Xolair PFS -Worked closely with commercial Drug Product Technical Lead (DPTL), Quality Product Lead (QPL), Global Complaints Management (GCM) and Manufacturing Site Lead to assure uninterrupted commercial supply- Led team through process qualification, design verification, and sBLA authoring for new assembly, labeling and packaging line for Xolair PFS- Prepared complaint descriptions and training material for complaint call center affiliates to prepare for launch of Xolair PFS. Worked closely with Global Complaint Management and QPL’s to complete complaint investigations and monitor complaint trends through Annual Product Quality Review (APQR).Device Testing Laboratories, Interim-Manager (June 2018 to January 2019)-Managed device testing laboratory group of 10 individuals who were responsible for lab equipment procurement/installation/qualification/CSV, equipment and facility maintenance, sample management, and laboratory testing-Established priorities and assigned resources for laboratory equipment qualification to align with Roche data integrity requirements and FDA 21 CFR Part 11 and 820 for use in design verification testing
EDUCATION
Purdue University
BS, Mechanical Engineering
Ball State University - Miller College of Business
MBA, Finance
ABOUT KAREN GRINKER
Principal Technical Manager at Genentech
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