Experience

ANI Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Data Reviewer, Quality Assurance and Compliance

  • Aug 2018 - Present



WellSpring Pharma Services Inc.

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Chemist, Raw Material

  • May 2016 - Aug 2018



Intellipharmaceutics International

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Analytical Chemist

  • Feb 2014 - May 2016



Pharmaceutical Science College of Canada

• North York, Ontario

• Pharmaceutical QA/QC Instructor

  • Nov 2013 - Feb 2014



Actavis (now Allergan)

• Pharmaceutical Manufacturing
• 700 & Above Employee

• R & D Analytical Chemist

  • May 2005 - Sep 2013

  -Performed complex chemical and physical analysis on the full range of analytical samples in accordance with established procedures. -Performed process qualification test, process validation test, release and stability testing of solid dose products, R & D products and raw materials. -Performed routine chemical and physical testing of solid dose products, including commercial products and blinded clinical trial materials. -Performed testing of new drug substances using combination of compedia and house (new) methods in order to generate data to establish product specifications. -Proficient in the use of analytical techniques and instruments specific to the laboratory section, such as chromatographic, spectrometric, electrometric, electronic and classical methodology. -Evaluated all results generated for consistency and accuracy and notified the supervisor of any trends or incongruities. -Technology/Instrumentation (type & complexity): UV, FT-IR, Karl Fischer Water tester, Auto UV & HPLC Dissolution, HPLC, GLC, TLC, Autotitrator, Malvern Mastersizer 2000 and other computerized equipment. Show less



Apotex Inc.

• Canada
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Chemist RD5, Analytical Operations Product Evaluation (AO-PE)

  • Nov 2002 - May 2005

  -Performed validation of analytical testing procedures for drug substances and drug products. -Tested samples for investigative/demonstrative stability studies on experimental formulations and drug substances, for products under development and using new methods (for generic and APO innovative products). -Conducted testing of accelerated stability samples for experimental (preformulation) batches to generate data to enable the optimization/ or confirmation of the formula.. -Performed alternate raw material supplier evaluations for existing products, in order to generate information regarding material suitability and data required for submisssion to Health Protection Branch for approval. _Performed comparative dissolution studies (APO products vs brand) in order to evaluate the suitability of the APO formulation for bioequivalence studies. -Performed dissolution testing on APO innovative products. -Technology/Instrumentation (type & complexity): UV, FT-IR, Karl Fischer Water Tester, KF Coulometrer, HPLC, disintegration, Auto UV & HPLC dissolution, TLC, AA, Autotitrator, Melting Point and other computerized equipment. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Oct 2002 - Nov 2002

  -Performed routine chemical analysis of raw materials, bulk products and finished products. -Prepared test samples and analyses dosage and/or raw material samples using instrumentation, according to established in-house and compendial methods and regulatory requirements. -Performed routine chemical analysis of raw materials, bulk products and finished products. -Prepared test samples and analyses dosage and/or raw material samples using instrumentation, according to established in-house and compendial methods and regulatory requirements.



Nucro-Technics Inc.

• Canada
• Research Services
• 1 - 100 Employee

• Chemist

  • May 2001 - Oct 2002

  -Performed various physical and chemical testing of raw materials, packaging materials, bulk products, finished products, stability products using AAS, UV/VIS, FT-IR, Karl Fischer, Autotitrator, Dissolution Tester and other computerized equipment. -Performed routine chemical analysis of raw materials, bulk products, finished products and stability products in accordance with client methods, USP, BP, EP, AOAC, ACS. -Performed various physical and chemical testing of raw materials, packaging materials, bulk products, finished products, stability products using AAS, UV/VIS, FT-IR, Karl Fischer, Autotitrator, Dissolution Tester and other computerized equipment. -Performed routine chemical analysis of raw materials, bulk products, finished products and stability products in accordance with client methods, USP, BP, EP, AOAC, ACS.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Analyst II

  • Jul 1988 - Feb 2001

  -Performed various complex physical and chemical testing of raw materials, packaging materials, in-process, bulk and finished products, post production product inspection, stability products, product complaints and returned goods using HPLC, GLC, UV/VIS, FT-IR, AAS, Polarography, Dissolution Tester, Karl Fischer, Autotitrator and other computerized equipment. -Performed calibration, maintenance and troubleshooting of laboratory instruments/equipment such as HPLC, GC, UV/ViS, FT-IR, AAS, Polarography, Dissolution Tester, Karl Fischer, Autotitrator and other laboratory instruments according to established methods. -Performed validation of test methods and equipment to ensure reliability of results obtained. -Assisted in preparation and review of method protocols, recommends updating of test methods used in the chemistry laboratory if updating became necessary. -Prepared monthly schedules for stability testing, labeled, stored and withdrew stability samples at different temperatures, monitored conditions of storage rooms/units and assigned stability samples to analyst. -Provided training and guidance to junior staff on an ongoing basis and assisted supervisor and less experienced analysts in resolving analytical problems and carrying out investigations and writing OOS reports. -Assisted the supervisor in review of COA's and stability reports. -Cross-trained in the Microbiological Laboratory for three months and prepared material required for microbiological testing of raw materials, packaging materials, finished products and environmental samples. -Assisted the microbiologist in taking samples for environmental monitoring and in determining levels of microbiological contamination. Tested chemicals used in the DI Water and Waste Water Treatment upon request by Engineering Department. -Performed in-process Quality Control operations and finished product inspection. -Performed Internal Quality Audit in the production area and laboratory. Show less



Unilab, Inc.

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Laboratory Technician

  • Jan 1988 - Jun 1988

  -Performed analysis of raw materials, in-process and finished products using conventional and wet chemical analysis and various instrumental methods of analysis. -Performed dissolution and disintegration testing on bulk and finished products.. -Performed analysis of raw materials, in-process and finished products using conventional and wet chemical analysis and various instrumental methods of analysis. -Performed dissolution and disintegration testing on bulk and finished products..



Department of Science and Technology (Formerly National Institute of Science and Technology)

• Manila, Philippines

• Apprenticeship Trainee

  • Jun 1986 - Aug 1986

  -Performed volumetric and gravimetric chemical analysis. -Performed volumetric and gravimetric chemical analysis.