Michael Shifflet
Montoursville,PA
Summary
Dynamic Quality Assurance Scientist IV at Johnson & Johnson with extensive experience in developing and validating analytical methods using HPLC and ICP-MS. Proven leader in cross-functional teams, ensuring compliance and quality in manufacturing processes. Strong attention to detail and commitment to excellence, complemented by a passion for mentoring future scientists. Identification of pharmaceutical impurities using GC-MS, and FTIR-microscopy
Overview
40
40
years of professional experience
Work History
Quality Assurance Scientist IV
Johnson & Johnson
03.1997 - 08.2026
- Developed and validated analytical methods using HPLC, UPLC, ICP-MS, Atomic Absorption, and UV.
- Created protocols for validation activities and prepared reports.
- Recorded observations and compiled results in laboratory notebooks and electronic systems with strong attention to detail.
- Created Analytical methods based off of the validated methods.
- Used FTIR-microscopy and gas chromatography to identify unknown substances encountered in pharmaceutical / consumer products and raw materials.
- Participated in and lead cross functional teams to investigate manufacturing issues.
- Lead Analytical support of manufacturing cleaning validation activities.
- Performed all of the activities above in GMP / ICH compliant manner.
Laboratory Technician (Chemist)
Merck Pharmaceuticals
03.1988 - 02.1997
- Performed GMP laboratory testing in compliance with SOPs, specifications, and safety requirements.
- Documented analytical results accurately in LIMS and maintained complete batch records.
- Calibrated, verified, and maintained laboratory instruments (HPLC, Atomic Absorption, IR) to support reliable test performance.
- Troubleshot assay deviations and equipment issues, escalating findings through proper quality channels.
- Executed sample preparation, reagent handling, and routine quality control assays with precision.
- Identified impurities using NMR.
- Develop and validated new methods to replace our older / outdated methods.
Head Chemist
Seewald Laboratories
08.1986 - 02.1988
- Performed testing activities from Standard Methods for Testing of Water and Waste Water.
- Worked with customers to determine what types of testing they needed to meet their goal.
- Used basic instrument like pH to Atomic Absorption and gas chromatography.
Education
Master of Science - Analytical Chemistry
Bucknell University
Lewisburg, PA04-1996
Bachelor of Science - Chemistry
Lycoming College
Williamsport, PA04-1986
Skills
- Laboratory techniques include HPLC, UPLC, Atomic Absorption, ICP-MS, GC and LC mass spectrometry, IR, FTIR-microscopy, pH and wet chemistry tests in the United States Pharmacopea
- Developing and validating analytical methods for pharmaceutical actives and preservatives
- Was the lead safety laboratory analyst for 15 years
- Participated on United Way Team for Lititz
- I am a Board Member for North Museum of Science of Nature and Science
- Participated as a judge for the Lancaster County science fair for 29 years
Timeline
Quality Assurance Scientist IV
Johnson & Johnson
03.1997 - 08.2026
Laboratory Technician (Chemist)
Merck Pharmaceuticals
03.1988 - 02.1997
Head Chemist
Seewald Laboratories
08.1986 - 02.1988
Master of Science - Analytical Chemistry
Bucknell University
Bachelor of Science - Chemistry
Lycoming College