Mark K Lee
Western University
Tell me more about Mark K Lee?
Mark K Lee is an experienced professional with 27.9 years of work experience in the medical devices industry. He has a strong background in R&D, FDA regulations, and six sigma. Mark has held various leadership positions in renowned companies such as Flex, Johnson & Johnson, Abbott, and Baxter International Inc. He is currently the Executive Director of Drug Delivery Program Management at Amgen. Mark's expertise lies in quality assurance, product development, and program management. He is based in San Francisco, California.
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About
Executive Director, Drug Delivery Program Management at Amgen
Work Experience
Chief Technology Officer
IT Services and IT Consulting
Mark K Lee's Professional Milestones
- Global Head Of Research And Development (2015-01-01~2017-01-01): Implementing innovative strategies to drive innovation and enhance technological advancements worldwide.
- Executive Director | R & Director Engineering | Drug Delivery Systems (2011-01-01~2016-01-01): Implemented cutting-edge pharmaceutical delivery systems to enhance system efficiency and ensure safe and efficient drug delivery.
Education
Engineering,
Doctorates,
Doctor Of Philosophy
1995-1999Skill
Medical Devices
R&d
Fda
Six Sigma
Cross Functional Team Leadership
Quality Assurance
Product Development
Program Management
Design Control
Biotechnology
Lean Manufacturing
V&v
Iso 13485
Validation
Capa
Manufacturing
Engineering
Strategic Planning
Quality System
Gmp
Product Launch
Start Ups
Commercialization
Biomedical Engineering
Pharmaceutical Industry
Change Management
Iso 14971
Technology Transfer
Biopharmaceuticals
Change Control
Risk Management
Design Of Experiments
Regulatory Affairs
Fmea
Lifesciences
Process Simulation
Drug Delivery
Medical Device R&d
Combination Products
Root Cause Analysis
Hardware Diagnostics
21 Cfr Part 11
Medical Imaging
Computer System Validation
Glp
Dmaic
Clinical Trials
Clinical Development
Regulatory Submissions
Systems Engineering
Certification
Colleagues
Other Named Mark K Lee
Frequently asked questions
We found 1 Mark K Lee's email addresses
We found 1 Mark K Lee's phone numbers
Mark K Lee's social media include: Linkedin,
Mark K Lee works for Flex
Mark K Lee's role in Flex is Chief Technology Officer
Mark K Lee works in the industry of IT Services and IT Consulting
Mark K Lee's colleagues are Revathi Advaithi,Rajiv Krishnan
Mark K Lee's latest job experience is Chief Technology Officer at Flex
Mark K Lee's latest education in Western University