1. REBECCA L. NICHOLS ic.beckynichols@yahoo.com
5123 Yates Place  Broomfield, CO 80020  303.469.0835
PHARMACEUTICALS/NUTRACEUTICALS/DIETARY SUPPLEMENTS/
MEDICAL DEVICES
 An innovative senior manager with extensive experience in applying technical solutions to complex
problems. Strong background in developing and leading teams in ensuring on-time delivery and high-
throughput laboratory operations by designing and implementing applied research operations for
process improvements.
 Proven ability to troubleshoot complex issues and design optimal solutions. Demonstrated success in
ensuring that solutions are designed to meet the specific needs and scope of the project with emphasis
on quality control, Standard Operating Procedures, optimizing analytical method development, and
utilizing uniquely crafted investigations and new technologies.
 Familiarity with cGMP, ISO, OSHA, FDA, and DEA regulations.
KEY ACCOMPLISHMENTS
 Managed method validations and drug product characterization protocols for ANDA filing.
 Company needed to validate six analytical procedures, including assay, content uniformity, and droplet
size distribution; and complete four drug product characterization studies in less than sixmonths to meet
the ANDA filing date for a generic drug product.
 Evaluated and updated all current methods and wrote step-by-step method validations and drug product
characterization protocols for a generic nasal spray product.
 Supervised the execution of the protocols and provided detailed technical review of all data and summary
reports. All testing was completed on schedule and the methods were validated.
 ANDA submission for the nasal drug product was completed per the requested schedule and FDA
approval was obtained.
 Turned around method transfer reproducibility and robustness issues to ensure production schedule.
 Reproducibility and robustness problems occurred during the transfer of a qualified high performance
liquid chromatography (HPLC) analytical test method to a contract laboratory causing possible delays in
production.
 Discussed non-compliance issues with laboratory personnel at each facility; evaluated analytical data and
information from both laboratories; recommended modifications to the instrumentation at the contract
facility; designed and supervised additional reproducibility and robustness experiments to monitor the
corrective actions.
 Successful transfer of the test method to the contract laboratory within the originally arranged production
time window was accomplished with no delay in the production schedule.
 Supervised the initial production and confirmed the acceptability of capsules for clinical trials.
 Team needed to incorporate an active ingredient with limited solubility into a pharmaceutical drug
formulation.
 Facilitated the evaluation of multiple excipients based on literature searches and previous experimental
results, formulated oral dosage mixtures for liquid-filled and soft gel capsules and designed simulated
biological systems to determine solubility. Created an oral dosage formulation for soft gel capsules that
overcame the perceived limited bioavailability due to the solubility of the active ingredient.
 Formulation transferred to an outside capsule manufacturer, personally supervised the first production
run at the off-site location, and confirmed the acceptability of the capsules for use in clinical trials.
SELECT POSITIONS
Manager Quality Control, Summit Biosciences Inc., Lexington, KY (Pharmaceuticals)
Quality Control Manager, HVL, LLC, Pittsburgh, PA (Dietary Supplements)
Analytical Chemist IV, Tapestry Pharmaceuticals, Inc., Boulder, CO (Pharmaceuticals)
QC Laboratory Manager, Meretek Diagnostics, Lafayette, CO (Pharmaceuticals/Medical Devices)
Staff Chemist, Hauser, Inc., Longmont, CO (Natural Products)