Software Skills

Microsoft Word
Microsoft Excel
Microsoft Office
Microsoft PowerPoint

Sector Experience

Healthcare
Life Sciences & Pharma
Fortune 500

Experience

Abbott Laboratories Management Consulting
Regulatory Affairs Associate (Contractor)
8/2018 - 4/2020
Abbott Established Pharmaceuticals Division (EPD) Regulatory Affairs (CMC) - Supported marketed registrations in emerging markets, including gap assessments and remediation of manufacturing site and regulatory documents to ensure regulatory compliance and alignment. Compiled and submitted regulatory filings to affiliates for international regulatory agencies.
AbbVie Management Consulting
Manager, Reference Standards
9/2014 - 4/2017
Oversaw the corporation’s global reference standards program, including procurement, characterization, continued suitability testing, storage, inventory, dispensing and global distribution of reference standards to all laboratories throughout the corporation, third party customers, regulatory agencies and compendial agencies worldwide.
Abbott Laboratories Management Consulting
Section Manager, Reference Standards Inventory and Dispensing
12/2003 - 8/2014
Abbott and AbbVie - Oversaw the corporations’ global reference standards inventory & dispensing operations, including procurement, storage, inventory, dispensing and global distribution of reference standards to all laboratories throughout the corporation, third party customers, regulatory agencies and compendial agencies worldwide.
Abbott Laboratories Management Consulting
Senior Research Analytical Chemist, Reference Standard Department
1/2002 - 11/2003
Assured timely submission and approval of reference standards interval testing to establish continued acceptability.
Established new and replacement reference standards, initiated method transfers from laboratories outside the department; supervised and performed compendial laboratory evaluations for products and reference standards continued acceptability testing to certify reference standards for continued use.
Abbott Laboratories Management Consulting
Senior Group Leader, Quality Control Production Laboratories
1/1998 - 12/2001
Managed two quality control production laboratories responsible for release testing of final bulk drug substances (APIs), intermediates and raw materials.
Abbott Laboratories Management Consulting
R&D QA Program Manager, Quality Assurance & Chemical Development
2/2000 - 11/2000
Managed the R&D Quality Assurance, a joint-venture of Quality and Chemical R&D Divisions. Developed associated quality systems to support development and manufacture of research and clinical APIs, including headcount, budgetary requirements and major roles and responsibilities.
Developed quality system for clinical lot validation and release
Abbott Laboratories Management Consulting
Senior Research Analytical Chemist, Analytical Research & Development
12/1992 - 12/1997
Provided analytical support for various custom projects for clinical material.
Provided analytical support for various Abbott chemical and fermentation products.
Conducted method transfer to QC labs.