John Johnson
Cincinnati,OH
Summary
Pharmaceutical chemist with a 13+ years of experience in GMP, quality control, technical development, method validation, regulatory compliance, project management and laboratory investigations. Striving to utilize analytical expertise and leadership abilities to drive compliance, productivity, and efficiency of organizational projects to maximize operational excellence.
Overview
12
12
years of professional experience
Work History
Senior Scientist – Quality Control
Andelyn Biosciences (formerly The Research Institute at Nationwide Children's Hospital)
06.2020 - Current
- Works in close collaboration with the QC Management to cultivate and enact strategic direction of the GMP area, including determination of schedule and project timelines/capabilities
- Writes and reviews the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within the QC laboratory (equipment and process SOPs) and ensures documents are written with proper scope, detail, and format to meet FDA guidance
- Provides QC Management with all laboratory data generated from QC laboratory tasks, including in-process, release, and stability testing
- Manages and reviews the compilation of all data and ensures its correctness
- Supports the proper operation, calibration, validation, cleaning, and maintenance of QC laboratory equipment and systems as specified in methods
- Assists in purchasing, shipment, contract negotiations, and communications with all external QC laboratory activities in coordination with QC Management
- Assists QC Management with the management of laboratory investigations, the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
- Works in close collaboration with the QC Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
- Works in conjunction with the QC Management to ensure new projects and technologies are sought for incorporation into the GMP laboratory.
QC Analyst II – Technical Development
Teva Pharmaceuticals - Cincinnati
02.2018 - 06.2020
- Supported product transfers by evaluating incoming methods, materials and instrumentation
- Performed analytical verification, validation and release testing on raw materials, finished products and stability samples
- Opened investigations as necessary and initiated root cause analysis of OOS data
- Authored, updated and reviewed SOPs, WINs, technical protocols and analytical procedures for product and material transfers
- Coordinated and led continuous improvement projects for operational excellence subgroup.
Quality Assurance Analyst, Weekender
Anheuser-Busch - Columbus
10.2015 - 04.2019
- Conducted routine analytical analyses on beer samples including: pH, alcohol, sodium, and iron
- Conducted routine analyses of packaged beer for oxygen, carbon dioxide, fill level, etc
- Performed routine testing of pasteurizers for proper pasteurization
- Conduct inspection and analysis of package integrity and specifications
- Coordinated quality analyses ensuring accurate results, timely completion, and proper responses and notification
- Performed duties of Packaging Operator when required - operate and monitor production equipment, perform line quality checks, & troubleshoot equipment.
Scientist II
Hikma Pharmaceuticals (formerly West-Ward Pharmaceuticals) - Columbus
03.2016 - 02.2018
- Authored, reviewed and approved technical reports, SOPs, WIs, protocols and analytical procedures
- Reviewed internal and external testing data with accuracy and consistency
- Released APIs, excipients, packaging and printed components to operations utilizing SAP
- Mentored and trained peers on instrumentation and analytical methods as TSMET certified trainer.
Scientist II
Boehringer Ingelheim Roxane Inc - Columbus
08.2014 - 03.2016
- Conducted material and product testing for multiple departments including Quality Assurance, Development (Analytical and Product) and QC Stability Life-cycle
- Coordinated and executed equivalency studies and method verifications for upcoming USP pharma forum changes
- Performed initial method evaluations and validation testing for new source APIs and excipients
- Participated in cross-functional groups to assess and implement process harmonization between lab departments
- Managed metrics and data tracking for productivity and efficiency of quality laboratories teams
- Led QC portion of records separation project following company acquisition
- Met all milestones to ensure proprietary information was appropriately segregated and allocated.
Scientist I
Boehringer Ingelheim Roxane Inc - Columbus
01.2012 - 08.2014
- Performed chemical and physical testing on API's, excipients and packaging components as directed by various pharmacopeias (USP/JP/EP)
- Executed USP method verifications, material evaluations and material transfers in accordance with internal SOPs and external regulatory guidelines (FDA/ICH/ISO/ASTM)
- Supported QC functions as Empower Superuser, Labware (LIMS) Superuser and Active Strategy Domain Administrator
- Exhibited strong instrumentation troubleshooting abilities and evolved into an SME on multiple technologies
- Gained extensive knowledge of cGXP's, regulatory requirements, company policies and industry guidelines.
Education
Master of Business Administration -
Northern Kentucky University
Highland Heights, KY01.2025
Bachelor of Science: Biochemistry -
The Ohio State University
Columbus, OH03.2010
Associate of Science: Chemistry -
Columbus State Community College
Columbus, OH06.2007
Skills
- Project Management
- Research Management
- Data Analytics
- Safety Processes and Procedures
- Results Analysis
- Assay Development
- Quality Control
- Training and Mentoring
Analytical Technique Experience
- GC / GC-MS
- HPLC / UPLC
- Laser Diffraction Particle Size (Malvern/Sympatec/Zetasizer)
- Dissolution
- Karl Fischer Moisture Analysis
- Titration
- FTIR/NIR/Raman
- Polarimetry
- UV/Vis/Fluorescent Spectroscopy
- Wet Chemistry
- DNA/RNA/Protein preparation and purification assays
- Electrophoresis
- qPCR
- ddPCR
- Cell based assays
Research Publications
- Quadruplex formation as a molecular switch to turn on intrinsically fluorescent nucleotide analogs., Johnson J, Okyere R, Joseph A, Musier-Forsyth K, Kankia B., Nucleic Acids Res., 01/07/2013, 10.1093/nar/gks975
- Isothermal amplification of DNA using quadruplex primers with fluorescent pteridine base analogue 3-methyl isoxanthopterin, Gogichaishvili S, Johnson J, Gvarjaladze D, Lomidze L, Kankia B., Biopolymers, 06/2014, 10.1002/bip.22421
Software Experience
· SAP/BEAS
· Labware LIMS
· LabVantageLIMS
· Empower
· Active Strategy
· Kalidegraph
· Trackwise
· Sigma
· Valgenesis
Timeline
Senior Scientist – Quality Control
Andelyn Biosciences (formerly The Research Institute at Nationwide Children's Hospital)
06.2020 - Current
QC Analyst II – Technical Development
Teva Pharmaceuticals - Cincinnati
02.2018 - 06.2020
Scientist II
Hikma Pharmaceuticals (formerly West-Ward Pharmaceuticals) - Columbus
03.2016 - 02.2018
Quality Assurance Analyst, Weekender
Anheuser-Busch - Columbus
10.2015 - 04.2019
Scientist II
Boehringer Ingelheim Roxane Inc - Columbus
08.2014 - 03.2016
Scientist I
Boehringer Ingelheim Roxane Inc - Columbus
01.2012 - 08.2014
Master of Business Administration -
Northern Kentucky University
Bachelor of Science: Biochemistry -
The Ohio State University
Associate of Science: Chemistry -
Columbus State Community College
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