Pharmaceutical Data Analysis
Resume:
Michele Landers
During my career I have worked with a variety of database software systems, inputting and extracting data, followed by analysis and interpretation of the data to determine emerging trends.
Experience
Education
2019 - 2025
QA Post Marketing Operations Regeneron Pharmaceuticals
Complaints received from patients and HCPs (Health Care Providers) were investigated to determine the root cause of the issue. This data was trended to discover and investigate excursions. Reports were written to document the investigations. For root causes related to manufacturing issues, CAPAs (Corrective and Preventative Actions) were initiated to correct the issue and/or prevent recurrence
2018 – 2019
Data Reviewer PharmAssist Inc.
Verified that all data produced and documented by my group of 5 analysts was performed correctly and compliantly relative to both internal and regulatory requirements.
2016 – 2018
Associate Stability Scientist Bristol Myer Squibb
Maintained compliance for the stability program for a global biologic drugs business including data entry and authorization, trending analysis of data and writing reports documenting the progress of the studies. Files were always maintained in audit-ready condition.
2015 – 2016
Coordinator of Quality Assurance Hospice of Chenango County
Applied the principles of compliance and analytics to evaluate the work of the various nurses relative to each other and measured against Medicare regulations and industry norms. Then I prepared reports for presentations to regulators and the governing board.
2012 – 2015
Stability Coordinator Norwich Pharma Services
2001 – 2012
Analytical Chemist, Release and Stability Testing OSG Norwich Pharmaceuticals
1993 – 2001
Analytical Chemist Procter & Gamble Pharmaceuticals
This series of jobs represents continuous employment at a company that changed hands several times.
Stability Coordinator: Working directly for the stability manager, I established and managed stability studies for in-house development projects and commercial products as well as a wide range of products for third-party customers. Management includes defining study protocols to meet different compliance needs, generating all documentation to establish and regulate the study and collecting data into a format appropriate for regulatory submission. Received certification from the DEA to work with controlled substances.
Analytical Chemist: Delivered analytical testing results for both release and stability samples with a focus on accuracy, reproducibility, real-time documentation and delivery within the timetable created by customer delivery commitments. Also functioned as SME (Subject Matter Expert) for questions generated during regulatory agency audits for the categories of cleaning validations and method /technology transfers.
1977 – 1986
Chemist, Stability Group CIBA-GEIGY Inc.
Performed routine wet chemistry analysis of stability samples. Techniques included GC, HPLC, TLC and UV-Visible Spectroscopy. Instrumental in bringing HPLC and dissolution analysis techniques into the laboratory. Implemented long-term dissolution technology in the laboratory (24-48 hour testing of delayed-release formulations and skin patches) including re-cycling flow systems, automated readings and data collection.
Computer Skills
Extensive experience in Microsoft Word, PowerPoint and Excel, including use of templates and spreadsheets. HPLC analysis collected and processed with Perkin-Elmer-Nelson TurboChrom and Waters Empower software.
Extensive experience with several aspects of the SAP Software system. In different job functions, I used it to collect release data to append the laboratory information to the production record and create a database that allowed SAP to schedule stability work on a daily basis, construct a framework forecasting daily/monthly stability revenues and provide a vehicle for automatically notifying the finance department that reports had been delivered and should be billed and provide documentation to generate certificates of analysis for product release.
Developed expertise in Sample Manager LIMS, including data entry and retrieval, report generation and trending.
B.A in Chemistry with Honors
Vassar College
Poughkeepsie, NY
Skills
Organized
Efficient
Attention to Detail
Analytical
Compliance-driven
Articulate
Contact
605 Pegg Rd
Morris, NY 13808
***********@*****.***
Contact this candidate