Quality Control Data
Resume:
Jonathon G. White
********.*****.****@*****.***
Summary of Qualifications
Familiar with compliance requirements within cGMP, cGLP, safety and regulatory environments.
Extensive knowledge of and experience in drug development and working in accordance with GMP requirements.
Experienced in numerous types of raw material testing.
Strong experience reviewing various data for accuracy, completeness and compliance.
Outstanding written and verbal communication.
Strong knowledge of USP and EP compendia.
Six Sigma Yellow Belt Certification.
Education
ECSU Elizabeth City, NC
B.S. Chemistry; Minor Biochemistry GPA 3.1
Instrumentation Skills
HPLC/UPLC (Agilent and Water), GC/MS (Shimadzu), GC/Headspace (Agilent), ICP-MS, Volumetric and Coulometric Karl Fisher, Flow Cytometry, FT-IR, UV-Vis, Dissolution (USP Apparatus 1 and 2), Practical Size (Malvern G3, Mastersizer 2000, Shimadzu), NMR, AT MD Fully Automated Dissolution Testing System (SOTAX)
Software Skills
Empower v3 (Analyst Privileges), Total Chrom, ChemStation, LIMS (Administrative Privileges), Tiamo, Documentum Compliance v6.5 (Administrative Privileges), MS Office (Excel, Word, PowerPoint)
Professional Experience
Analytical Research and Development Scientist I at Pfizer
September 2016 to Present
Write and review formal protocols and reports for development studies.
Communicate timelines for critical path items to ensure on-time deliverables and successful execution of studies.
Design, conduct and manage experiments related to the development of drugs in-house.
oHelped design and implement dissolution protocol for Japanese Regulatory filing.
Contribute to regulatory filings; ICH and Japanese Ministry of Health and Welfare.
Communicate timelines for critical path items to ensure on-time deliverables and successful execution of studies.
Analytical Chemist / Special Projects Coordinator at Pfizer
September 2014 to August 2016
Provide Analytical testing support to Pfizer Inc. Singapore client.
Reviewed protocols, instrumentation, and testing data for accuracy, completeness and GMP compliance.
Documentum Administrator.
Performed various types of raw material testing including but not limited to HPLC, Karl Fisher, Titration, Gravimetric, Optical Rotation, Density, Heavy Metals, and Arsenic.
Followed USP and EP compendia.
Responsible for the introduction of RS methods, specifications, and relevant historical information into PDOCS.
Performed weekly logbook checks.
Assisted with method development, transfers and validations.
Conducted routine testing on Stability Standards (Volumetric, Coulometric Titrations, NMR, HPLC and FT-IR analysis).
Nutramax Laboratories
Quality Control Analyst II
October 2013 to March 2014
Performed analytical chemistry assays based on new and existing methodologies,
Operated/calibrated analytical instrumentation such as HPLC, GC, FTIR, Titrator, Particle Size Analyzer, ICP-MS, etc.
Developed, established, and validated analytical testing methodology used to control raw materials, production intermediates, and final products.
Performed various types of raw material testing including but not limited to HPLC, Karl Fisher, Titration, Gravimetric, Optical Rotation, Density, Heavy Metals, and Arsenic.
Followed USP and EP compendia.
Wrote LIRs and technical reports to document analytical methods.
Transferred documented analytical methods to the QC department.
Ensured compliance with cGMPs.
Empower v3 Analyst privileges; method development, troubleshooting.
Reviewed protocols, instrumentation, and testing data for accuracy, completeness and GMP compliance.
Responsible for OOS and OOT investigations and write-ups.
LIMs administrator privileges.
Maintained site wide push through of raw materials and generation of Certificate of Analysis for US and International clients.
Coordinated with Manufacturing to maximize product reliability and minimize cost.
Cadista Pharmaceuticals
Quality Control Chemist II
October 2012 to September 2013
Performed analytical testing of pharmaceutical dosage forms on finished, intermediate and raw material products including: Dissolution Apparatus 1 & 2, HPLC, GC, Spectroscopy, FT-IR, UV-VIS and wet chemistry analysis.
Performed various types of raw material testing including but not limited to HPLC, Karl Fisher, Titration, Gravimetric, Optical Rotation, Density, Heavy Metals, and Arsenic.
Followed USP and EP compendia.
Maintained laboratory notebook, logbooks and other documentation in accordance with cGLP designed to comply with cGMP.
Empower v3 Analyst privileges; method development, troubleshooting.
Johnson & Johnson (Noramco)
Quality Control Chemist I
April 2011 to July 2012
Performed analytical testing of pharmaceutical dosage forms on finished, intermediate and raw material products CII-CIV including: UPLC/HPLC, GC, FT-IR, UV-VIS, Particle Size, Karl Fisher and wet chemistry analysis.
Technical expert on Agilent GC/Headspace methods and troubleshooting.
Reviewed protocols, instrumentation, and testing data for accuracy, completeness and GMP compliance.
Provided technical expertise to internal customers, other lab personnel and contract laboratories.
Assured accurate and timely input of QC data in to LIMS.
Coordinated and performed calibration of new and existing laboratory instruments to ensure reliable, prompt, precise and accurate test data; troubleshoot and perform minor maintenance/repair of lab instruments.
Empower v3 Analyst privileges; method development, troubleshooting.
Catalent Pharma Solutions
Laboratory Coordinator
August 2010 to March 2011
Ensured individually and as a part of the Inhalation Formulation team, the overall effectiveness and efficiency of project implementation by supporting Project Directors, Managers, Team Leads, and Analysts.
Reviewed protocols, instrumentation, and testing data for accuracy, completeness and GMP compliance.
Developed and implemented policies, procedures, and standards for lab operation to ensure the efficiency, effectiveness, and quality control of the laboratory and compliance with federal and state standards i.e. Six Sigma/Lean laboratory organization and laboratory safety inspections.
Provided support and assistance related to facilities and equipment issues and repairs.
ECSU
Lead Researcher
August 2005 to May 2010
Experimented with medicinal plant extracts from Zimbabwe that may serve as therapeutic targets for Alzheimer disease and CDK-5; by inhibiting caspase-3 and Beta-amyloid production.
Responsible for the development and implementation of a new testing protocol for analysis of Zimbabwe Medicinal Plant Extract Inhibition or Excitation on PC-12 cell viability using Flow Cytometry.
Responsible for the development and implementation of a new testing protocol for analysis of; Up-regulation of TLR1, TLR2 and TLR4 expression in innate immune cells induced by TPA: Role in the potentiation of inflammatory and oxidative stress responses to LPS and LTA using GC-MS.
Assisted in the data contribution, writing and editing process of the National Institute of Health (NIH) grant that was awarded $1.6 million from the Research Support Research Initiative for Scientific Enhancement.
Sandoz (Novartis)
Quality Control Chemist I
April 2007 to June 2008
Followed established standard operating procedures and methods to plan and conduct analytical testing within the work-group.
Worked with supervisors to plan and complete testing, data evaluation and LIMS reporting.
Identified suspect data and worked with management to complete investigations.
Conducted all testing in compliance with (cGMP/GLP) and SOP’s.
Maintained proper documentation of laboratory data (which requires adequate proficiency in written and computational skills).
Extensive advanced analytical instrumentation experience, including: analysis and calibration using HPLC, GC, Particle Size, FT-IR, AA and UV-VIS instrumentation.
Assisted in the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, efficacy and reliability of products.
Utilized analytical (wet chemistry) techniques for testing of raw materials.
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