• Provide services for analytical development, QC and CMC strategy building and outsourcing• Oversee and manage Contract Manufacturing Organizations (CMOs)’s drug development and quality control. • On behalf of clients, work with CMOs to deliver project timelines, conduct audits and investigations• Review and approve project related methods, protocols, reports, specifications and Certificates of Analysis.• Prepare QOS, IND and NDA documents (CMC sections) for regulatory submissions in Canada and US. (completed 4 submissions in 2022)• Conduct GMP audits and prepare audit reports. • Help client to apply GMP site license and Natural Product Numbers from Health Canada.• Conduct GMP audit for clients.

• Oversee all the projects related to chemistry, manufacturing and quality control.• Drug product development and Analytical development for drug substances and drug products.• Help clients to develop early phase products for clinical trial studies.• Lead Formulation Development and Analytical Development for NCE and generic drugs.• Provide project management for all product development projects.• Prepare IND and NDA submissions for clients.

Business Development

• Oversee day-to-day quality operation activities• Conduct investigations into failed results or deviations (product, stability, process and procedures) and ensure investigations are initiated following procedures.• Identify the root cause and take corrective and preventative actions. Review the product failure investigation reports and approve. • Conduct internal audit and prepare annual quality report.

Supervise an anylytical R&D group of 8 chemists. Performed high-calibre project planning and management in support of several client contracts, routinely attending and presenting for project-related client discussions; ensured consistent delivery of on-time, high-quality services. Selected accomplishments:• Initiated and reviewed product specifications, COAs, stability protocols, DR, OOS /deficiency reports and analytical methods.• Scheduled test for API, in-process, bulk, and finish product, release tests and stability studies.• Ensured testing is performed accurately and in compliance with GMP, USP, SOP and approved analytical methods• Managed over 10 product analytical development projects from preclinical through New Drug Application (NDA), including Investigational New Drug (IND) phases I, II, and III; coordinated development of an array of different dosage forms for new drugs (nasal spray, tablets, capsules, powder, oral solution, topical gel / ointment).• Attended cross-function meetings and teleconferences with clients as analytical laboratory representative. • Reviewed and approved analytical documents of products and active pharmaceutical ingredient (API) prior to release; facilitated product commercialization and transition to manufacturing stage.• Prepared for FDA and client inspection.• Standard and control substances coordination.

Hold full responsibility for contract laboratory and product development services, managing product development, validation processes, protocols and technical transfer to GMP manufacturing site. Establish SOP across a diverse array of contract analytical laboratory processes, ensuring superior laboratory quality and consistently safe operating environments. Manage team of 6 Chemists. Plan, coordinate, and conduct internal audits. Selected accomplishments:• HPLC, dissolution and GC troubleshooting and coordinating for instrument maintenance.• Provided contract laboratory services to major pharmaceutical clients in analytical development, impurity identification, and formulation development. • Deviation investigation and CAPA management• Directed laboratory activities in alignment with ICH guidance and GMP requirements of Health Canada and FDA• Oversee lab equipment maintenance; schedule regular calibration and performance verification (PV) activities.• Reviewed and approved SOPs, change of controls, protocols and reports • Provided training to all chemists of SOPs, methods, laboratory instruments and techniques. • Promoted and maintained safe and healthy working environment.• Conducted internal audit and gap analysis for clients’ analytical laboratories.

Built impressive record of achievement and advancement through series of progressively responsible positions leading analytical development projects and laboratory operations, advancing into supervisory role for the Analytical Development group of 6 to manage drug development efforts across the development life cycle.