Wayne Jensen Email & Phone Number

Melbourne, VIC, AU

Melbourne, Victoria, Australia

Consultancy service supporting the operational and business success of SME medtech companies in the areas of;*Advisory support for strategic business decision making*R&D Oversight*Project / Program Management*ISO 13485/9001 compliant R&D and Design Control process implementation / management*Advice on verification and validation of medical devices in.

Wendouree, Victoria, Australia

Delivering on the development of ISO13485 and FDA compliant medical devices with appropriate evidence of Quality, implementing appropriately tailored regulatory strategies to facilitate expedited approvals. Ensuring manufacturing operations for supply of product meets with ongoing requirements of customers and collaborators. Key Contributions:*Led Quality.

Melbourne, Australia

• Drive the operational management and expansion of the R&D programme from concept through to commercial manufacture at INOVIQ, involving both internally and externally sourced technologies. Key Contributions:
• Securing exclusive world wide licence agreement with Adelaide University with rights to a potential pan cancer diagnostic based on SubB2M detection technology.
• Proposed and executed on plans for the relocation of Melbourne based facility into a larger warehouse facility… Show more Drive the operational management and expansion of the R&D programme from concept through to.
• Proposed and executed on plans for the relocation of Melbourne based facility into a larger warehouse facility, providing the company with the capacity to set up expandable cGMP manufacturing operations.
• Executed technology transfer of product technologies as appropriate to third party contract cGMP facilities (Singapore and USA)
• Supported the critical assessment and selection of external project opportunities, which has generated a strong pipeline of R&D opportunities in the cancer diagnostic space. Show less

Rowville, Vic

• R&D project management for point-of-care diagnostic tests in coagulation field. Assemble, coach, deploy, and monitor high-performing scientific team for seamless operations in strip development and manufacture. Ensured.
• Established and chaired a New Opportunities Review Committee, to identify new product development opportunities for the R&D pipeline.
• Contributed to the successful development of UBS’s first commercially available PT/INR product, enabling the company to expand product line and market share.
• Directed all aspects of second coagulation test strip development from concept to verification stage.
• Presented expert insights in the establishment, administration, and analysis of clinical trials’ results organised in both Australia and the USA in the initial stages and via CRO’s at the later stages.
• Delivered functional support to regulatory clinical trials in the USA to enable regulatory submissions to countries including the FDA, the EU and Japan through documentation. Show less

• I expanded business by managing all aspects of product R&D operations for a unique pan cancer diagnostic test based on the measurement of telomerase in a start-up company. I identified and evaluated alternative.
• Recommended withdrawal from a challenging test based on reverse transcriptase quantitative PCR, to a more marketable technology platform based in the area of immunocytochemistry. The implementation of this.
• Designed strategic project roadmap for new product development through to market release while complying with regulatory requirements and policies.
• Formulated guidance document for the establishment of a cGMP manufacturing facility with an aim to manufacture IVD products for international release. Show less

• I spearheaded product research and development operations conforming to the requirements of ISO 9001 and ISO13485 quality assurance standards, with market release in compliance to US (FDA), European IVD Directive, and.
• Released 11 diagnostic tests and six serum free media to local and international markets through effective research and management efforts.
• Generated revenue ~ $300K pa by sourcing key account customers for Biosciences business.
• Maintained a trajectory of growth while avoiding obstacles that arise from constantly changing demands of four to five R&D staff members and operations.Additional experience as a Quality Assurance Manager for Thermo.