University of Ottawa

Director, Manufacturing Sciences & Technology at Tetra Bio-Pharma

Led & managed Contract Development Manufacturing Operations (CMDO) facility ensuring clinical trial drug supply met patient recruitment demands according to budget, timeline, quality requirements, and corporate milestones

Directed onsite Production Operations team and managed overall small-scale drug production facility operations consistent with the established quality management system and applicable current good manufacturing practices (cGMP) regulations & licensing requirements

Coordinated the development of novel & improved existing small scale cGMP manufacturing processes from initiation to clinical use, including establishing in-process, and chemical manufacturing controls consistent with applicable regulations and supporting department requirements

Established global timelines, scale-up plans, and budgets for the overall Manufacturing Operations department in accordance with the corporate drug development strategy

Facilitated business partner discussions as a key liaison, negotiated, drafted and reviewed vendor and large-scale supplier contracts, and performed critical analysis of novel business ideas, including identifying potential risks and opportunities, for upper c-suite management consideration

Collaboratively established & managed large-scale logistics, warehousing and supply chain for a ready to launch commercial drug product consistent with multiple, diverse regulations and quality requirements

Routinely provided project updates to external stakeholders, c-suite management, and internal complementary departments

Effectively managed all production planning, warehousing, inventory and procurement, including controlled and highly regulated materials, ensuring sufficient drug supply and limiting waste/expenditures

Effectively identified resources needed, provided feedback, training and team support, and built Manufacturing Operations team to meet critical department milestones

Tetra Bio-Pharma

Director, Manufacturing Operations

Project lead responsible for managing drug manufacturing scale-up and technology transfer of novel production processes, while maintaining a cGMP compliant quality system and associated budgets.

Involved in process improvement, quality risk analysis, regulatory compliance and regulatory affairs activities associated with multiple drug product development pipelines.

Effectively applies strong scientific background, understanding of complex regulations and critical thinking skills to solve novel problems across broad departments consistent with the core business goals.

Director, Manufacturing Science & Technology

Efficiently directed and managed various pre-clinical and clinical projects to meet specific objectives and milestones

Effectively managed and directly supported operation and quality assurance activities and objectives, as well as actively played a critical role in preparing and responding to regulatory audits and requests for information

Researched, drafted and managed multiple Orphan Drug Designations and played an active role in drafting and managing communications with regulatory bodies, including Health Canada and the FDA

Senior Program Director, Research & Development 

Research scientist focused on developing novel cannabis based drugs to treat human disease

Research Scientist

Basic scientific researcher studying early development, hematopoiesis and cancer development in the Lohnes lab

Postdoctoral Fellow

Provides advice and guidance, based on academic scientific training, in collaboration with the CEO and fellow business partners about future business ventures and activities through compiling comprehensive research reports and group discussions.

Tetra Bio Pharma Inc. (formerly GrowPros Cannabis Ventures Inc.)

Consultant

Performed basic research focused on the development of the central nervous system

Randy Ringuette