Linda Kramer Email & Phone Number
President and Owner
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Linda Kramer Location
- Royersford, PA, US
Linda Kramer Work
- 2021 -now President and Owner @ LK CMC Compliance Consulting LLC
- 2020 -2021 CMC Regulatory Lead Spark Therapeutics @
- 2014 -2020 Director Global Regulatory Affairs @
- 2005 -2014 Associate Director Regulatory Affairs @
- 2005 -2005 Sr QA Compliance Associate @ Centocor
- 2002 -2005 Sr Process Scientist @ Centocor
- 2000 -2002 QA Supervisor @
- 1997 -1999 QA Supervisor @
Linda Kramer Education
- Temple University
Master's degree (Quality Assurance/ Regulatory Affairs)
2005 - Cedar Crest College
Bachelor's Degree (Chemistry)
1983-1987
Linda Kramer Skills
- GMP
- Regulatory Submissions
- 21 CFR Part 11
- CAPA
- FDA
- Biopharmaceuticals
- Regulatory Affairs
- Change Control
- Validation
- Pharmaceutical Industry
- Biotechnology
- Sop
- Technology Transfer
- Quality Assurance
- Quality Auditing
- Vaccines
- Regulatory Requirements
- Aseptic Processing
- Process Improvement
- Quality System
- Compliance
- Regulatory
- Leadership
- GLP
- Public Speaking
- C++
- Management
- Biochemistry
Linda Kramer Summary
- Linda Kramer, based in Royersford, PA, US, is currently a President and Owner at LK CMC Compliance Consulting LLC. Linda Kramer brings experience from previous roles at Spark Therapeutics, Inc., GSK and Centocor. Linda Kramer holds a Master's degree in Quality Assurance/ Regulatory Affairs @ Temple University. With a robust skill set that includes GMP, Regulatory Submissions, 21 CFR Part 11, CAPA, FDA and more. Linda Kramer has 2 mobile phone numbers on RocketReach.
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