Luis Martinez Email & Phone Number

Cambridge, Ontario, Canada

- Planning and coordination of the activities of validation, verification, and method transfer for Active Pharmaceutical Ingredients (APIs) and excipients for injectable formulations. - Author Validation, Verification, Method Transfer Protocols and Reports and their respective test methods.- Managing the documentation of the Pharmaceutical Development.

Mississauga, Ontario, Canada

• Actively involved in analytical method development, qualification/validation, and method transfers by developing raw material, in-process control, intermediate control, and API test methods and ensure that they provide.
• Planned and performed analytical method validations as per ICH guidelines.
• Executed forced degradation (stress) studies.
• Author Analytical methods and method development/qualification/validation reports.
• Performed instrument calibration/performance verifications.
• Member of the Joint Health/Safety committee

Mississauga, Ontario, Canada

• Prioritized and executed various GMP/non-GMP stability studies as per Protocol and Client requirements
• Conducted peer review of critical non-GMP analyses of process development samples.
• Performed standard qualification and standard requalification testing.
• Author stability protocols and reports
• Supported investigations related to Quality events (OOS/OOT/Deviations), Performed root cause analysis to influence decisions for continuous improvement.
• Stability SME for Client audits and Health Canada audits

Colombia

• Analyzed raw materials, in-process compounds, finished products to ensure quality. Validated records and analytical methodologies by testing samples and CRMs with IC, HPLC, GC, AA, ICP, TOC, UV and wet chemistry..
• Prepared testing items and assessed homogeneity and stability of final products according to ISO 13528 standard.
• Received training for several analytical methods of analysis related to job-related functions. Completed many programs to better lead and coach other staff while working in a team lead position.
• Trained and monitored laboratory technicians technical competence, performance, and their development. Trained technical directors of different public health laboratories, in order to standardize the quality-monitoring.
• Designed and implemented an integrated quality management system, based on ISO 9001:2008, ISO/IEC 17025:2005 and ISO 17043:2010 standards, supporting the documentation, implementation and assessment processes needed.
• Properly documented all results obtained from monitoring water samples while adhering to quality standards to ensure continuity and uniformity of all result collection.

Colombia

• Notified and served as the main point of contact for customers regarding the status of filed applications before the Patent Office. In addition, developed strategies to respond to the objections related to the novelty.
• Supported customers throughout the Patent application and during the processing of the application.
• Served as a consultant for those looking to file a Patent and advised applicants during the various parts of the application to ensure Patents were filed correctly.
• Taught customers about European Patent Office or the United States Patent Office searches and advised customers on technical requirements, changes that would need to be made to their applications and additional.

Colombia

• Analyzed different types of water, wastewater, sludge, soils and air samples using cutting edge analytical instruments and lab techniques to determine the amount and concentration of contaminants or pollutants present.
• Gained several accreditations for analytical methods of analysis. Some include IC, HPLC, GC, AA, ICP-OES, TOC, UV-Vis, wet chemistry for environmental management, water quality management and wastewater plant operation.
• Worked within a team of quality analysts to ensure proper record/data storing or collection and to meet lab due dates for sample analysis.