Nicholas Hon Email & Phone Number

• Extensive and comprehensive understanding of the Canadian reimbursement landscape demonstrated through leading and supporting over 52 new drug, new indication, line extension, and biosimilar submissions to public and private payers across a vast range of therapeutic areas.• Showcased exceptional project management skills by managing up to eight concurrent projects and overseeing the completion of key submission dossier components (including BIMs and Clinical Evidence Templates).• Developed and executed pCPA negotiation strategies for products that successfully concluded with LOIs resulting in accelerated provincial time-to-listings, surpassing average benchmark timelines.• Planned and moderated several advisory board meetings, involving ex-payer and clinical expert advisors from diverse backgrounds, aimed at gaining insights on challenges and establishing solutions to access of medications.• Performed multiple landscape assessments and analyses to identify risks and opportunities that drove critical market access and pricing strategies, ensuring positive HTA recommendations and successful pCPA negotiations.

• Performed two quarterly microbial and air particulate environmental monitoring of all areas inside manufacturing facilities under current good manufacturing practice (cGMP) regulations.• Conducted autoclave verification spore tests for dental clinics, medical centres, and other clients.• Performed general lab maintenance to maintain cleanliness on a daily basis.• Prepared and conducted microbial limit tests including the preparation of growth media.

Whitby, Ontario

• Prepared and executed Installation and Operational Qualification (IOQ) protocols for equipment and facilities validation, and Qualification Reviews (QRs) to confirm the validation of equipment.• Assisted in consolidating Quality Control (QC) and Testing Results for Process Validation Protocols and Reports.• Followed all Good Manufacturing Practices (GMPs), Standard Operating Documents (SODs) and Safe Work Practices (SWPs) as required by company policies and industry regulations.• Developed client management skills.• Gained thorough exposure to equipment, process, packaging, and cleaning validation.

Richmond Hill, Ontario

• Authored three Standard Operating Procedures (SOPs) to be uploaded to global company intranet and used by employees at the Richmond Hill site.• Developed and executed Installation and Operational Qualification (IOQ) protocols for the first track and trace capable liquid dose packaging line owned by Apotex.• Assisted engineers in an on-going project to implement serialization regulations to pharmaceutical products produced at the Apotex Liquid Dose site in Richmond Hill.• Followed all Good Manufacturing Practices (GMPs), Standard Operating Documents (SODs) and Safe Work Practices (SWPs) as required by company policies and industry regulations.• Liaised between contractors, production engineers, production technicians, maintenance technicians, quality control, and warehouse technicians to carry out the installation of new equipment.

Master’S Degree, Biotechnology

Activities and Societies: Varsity Badminton Team, Captain

Bachelor’S Degree, Biotechnology

Activities and Societies: Varsity Badminton Team, Duke of Edinburgh's Award: Waterloo Chapter