Heather Cain, Cpa, Msc Email & Phone Number

Vancouver, Bc, Ca

Vancouver, British Columbia, Canada

Vancouver, Canada Area

Vancouver

Vancouver, Canada Area

- Entered adjusting journal entries, closed temporary accounts at year-end, recorded reversing journal entries, posted bank and credit card business transactions throughout the accounting period, and conducted monthly reconciliations for professionals ranging from dentists, physicians, lawyers and architects to real estate developers.- Confirmed income tax, payroll tax and GST remittance payments with the Canada Revenue Agency.- Solid understanding and experience with QuickBooks Premier software.- Valuable working knowledge of CaseWare Working Papers, Doc.It Suite and TaxPrep software.

Vancouver, Canada Area

- Major contributor in establishing, maintaining and enforcing, through the conduct of documented audits and inspections, the Bioanalytical Chemistry department GLP system established to support the Phase I study of Cardiome's clinical drug candidate, GED-aPC, for the treatment of cardiogenic shock.- Contributed to and performed QA review on sections of the DMF for Cardiome's lead anti-arrhythmia drug, vernakalant hydrochloride, detailing control of drug substance (batch analyses), characterization (impurities) and pharmacokinetic studies and gathered, revised, and approved various supporting source documents.- Author of numerous SOPs and equipment qualification protocols in compliance with FDA, OECD and ICH guidelines.- Established and enforced Bioanalytical Chemistry department SOPs.- Managed, supervised Research Associates on and performed the release testing of new drug candidates and reference standards, in addition to the process development testing required to facilitate the submission for approval of Cardiome's lead anti-arrhythmia drug, vernakalant hydrochloride. The intravenous formulation of this drug, BRINAVESS, is approved for market in Europe and the oral formulation is in Phase II clinical studies.- Fulfilled departmental Director responsibilities in his absence.- Reviewed for compliance to departmental and corporate SOPs and assured the accuracy of supporting characterization data for new drug candidates. Established analytical reports and isomeric potency/purity reports for new drug candidates and established retest dates.- Conducted in vitro ADME studies such a Cytochrome P450 enzyme IC50 determinations using pooled human microsomes employing GraphPad Prism software and metabolic stability assessments using thawed cryopreserved plated human hepatocytes.

Vancouver, Canada Area

- Utilized Beckman Coulter P/ACE MDQ Series Capillary Electrophoresis systems with UV/PDA Detection operated using 32Karat software, Waters Alliance HPLC systems built around 2695 Separation Modules and 2996 Photodiode Array Detectors operated by Empower software and a Waters Quattro Premier XE mass spectrometer with triple quadrupole detection operated using MassLynx software to conduct various departmental studies.- Created and maintained proprietary compound dossiers, analytical reports, and Material Safety Data Sheets (MSDSs) in the corporate document control system, MasterControl.

Vancouver, Canada Area

- Significant contributor to the oral and intravenous dose formulation development of Cardiome's Phase II clinical new drug candidate, oxypurinol, for the treatment of congestive heart failure. A Varian VK7010 Dissolution Tester with a VK8000 Fraction Collector was utilized for this work.- Established, maintained, and supervised the in-house reference standard inventory and preclinical and clinical biological study sample inventories.- Supervised the coordination of internal and external supplies of proprietary compounds and ensured that detailed and accurate records of these activities were kept.

Vancouver, Canada Area

- Developed and implemented analytical methods to characterize non-formulated and formulated new drug candidates, selective signal transduction inhibitors for the treatment of ovarian cancer, using an Agilent 1100 Series HPLC/UV and assisted in the transfer of these methods to external collaborators.- Analysed new drug candidates using a MicroMass Q-TOF LC/MS system.- Responsible for the distribution of formulated and non-formulated new drug candidates for in vitro and in vivo pre-clinical studies, both internal and external, and maintained the new drug candidate inventory.- Prepared internal in vivo study samples for pharmacokinetic and efficacy analysis, performed using a MicroMass Quattro LC/MS/MS system, by employing a liquid-liquid extraction method.- Principal investigator in the dose formulation development of new drug candidates for use in vivo.- Gained supervisory experience by managing two co-op students.- Designed, executed, and documented pre-clinical experiments independently and analysed, evaluated, and presented the data internally.

Vancouver, Canada Area

- Developed a novel analytical assay for SPL7013, a patented polyvalent, polylysine dendrimer, using a Beckman Coulter P/ACE MDQ Series Capillary Electrophoresis System with UV/PDA/LIF Detection. SPL7013 is the Active Pharmaceutical Ingredient (API) in a topical microbicide gel currently in Phase I clinical trials used for the prevention of human immunodeficiency virus (HIV) and other sexually transmitted diseases in women.- Validated analytical assays under strict quality controlled GLP conditions suitable for regulatory approval.- Performed impurity and stability testing of raw materials, intermediates and finished formulated products in all phases of pre-clinical development according to established protocols/procedures based on FDA and ICH guidelines.- Developed highly sensitive and robust analytical assays for novel compounds where difficulties of isomer separation, sensitivity, and detection arose with other conventional approaches.- Designed and conducted experiments on API in a precise, accurate, and efficient manner.- Recorded, interpreted, analysed, organized and reported experimental data in addition to, the author of numerous SOPs in compliance with GLP guidelines.- Assisted with the supervision, teaching and training of other technical personnel and research associates.

Edmonton, Canada Area

- Manages between 18-20 students per Analytical Chemistry 211/213 laboratory session and Introductory Chemistry 101 laboratory session and successfully taught them how to obtain part per thousand accuracy through automated measurement utilizing the following analytical instrumentation: HPLC, GC, UV-Vis spectrometry, AA, direct potentiometry using an ion-selective electrode, geiger counter, automated glucose analyser and titrator.- Demonstrated strong leadership, teaching, communication, and interpersonal skills. Concurrently cultivated excellent organizational, scheduling and troubleshooting abilities.

Medicine Hat, Canada Area

- Responsible for the receipt of various clinical specimens, ensured the accuracy of patient information, performed dip-stick urinalysis, prepared cytology slides for microscopic examination and prepared blood specimens for further testing by the Haematology, Cytology and Clinical Chemistry departments.- Gained hands-on experience with phlebotomy and valuable teamwork experience.

Cpa Pep, Accounting And Business/Management

Cpa Prep Program, Accounting, Gpa 88.42%

M.Sc., Analytical Chemistry

Thesis: "Fluorescent Derivatization of Arginine- and Carbonyl-Containing Analytes for Analysis by Capillary Electrophoresis.

B.Sc., Specialization In Chemistry

Bachelor’S Degree, Pharmacy

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