Marcus Mcmillan Email & Phone Number

Santa Rosa, Ca, Us

Foster City, Ca, Us

Site OperationsElectrical ReliabilityOPEX/CAPEX Projects Planning & Execution

I utilize my competencies in Project Management, Problem Solving, Leadership & Strategic Planning to solve problems and provide value for my clients in the Medical Device/Life Science Industry.AchievementsSuccessfully coordinated the creation of a pre-IDE submission defining the strategy, scope and methods to demonstrate the efficacy of a Medical Device developed in Sydney 2003 (OAT Calibrator 510k)Design Development Plan – Created Product Requirements document and Requirements Traceability Matrix while integrating Regulatory Guidelines from FDA, CLSI, ISO, CE (OAT Calibrator 510k)Successfully coordinated the creation of a pre-IDE FDA submission defining the strategy, scope and methods to demonstrate the efficacy of a Medical Device for diagnosing von Willebrand’s Disease (ELISA Collagen Binding Assay 510k)Created the Risk Management Plan, Master Project Schedule, Master Validation Plan, IQ/OQ/PQ for Critical Equipment and 510k Medical Devices during a Facility Relocation

Danville, Ca, Us

Contracted to Gilead Sciences

Hercules, Ca, Us

I was responsible for the Technology Transfer of digital PCR reagents from the R&D facility to the Manufacturing facility. This involved establishing and leading cross functional teams at all levels of the business from R&D, Product Development, Manufacturing, Operations, Inventory Management, Marketing and Vendor Management. I was responsible for creating and monitoring Master Schedules for all activities, reporting to divisional managers and their respective employees.I managed a project team from 2 different sites and coordinated the activities necessary to ensure the Product Development Process between both facilities was aligned and delivered according to the product requirements and schedule.A highlight was leading the team to deliver the first reagent for the QX200 platform through the Stage Gate Product Development system on schedule and with no exceptions.All other reagents/consumables were transferred from the R&D site to the Manufacturing facility before the end of 2013. This enabled the R&D facility to focus on creating new products to support the new technology platform and maximize 1st mover advantages while the manufacturing facility exploits economies of scale and experience to increase the volume of existing products to the expanding ddPCR market.

I utilized my new business and PMP skills to manage multiple international projects; I relished the responsibility of being the face of the company with both our international customers and global internal departments.International Technology Transfer – responsible for the transfer of a 510(k) medical device from the US facility to the client site in Germany (Siemens); strategic master plan, risk management plan, quality plan, procurement plan, monitoring and control of activities at DSRV and client site, statistical analysis and final report. Project successfully completed on schedule in 12 monthsBusiness Development Strategy – created the feasibility study and project charter for FDA “de novo” ELISA Collagen Binding Assay. Secured clinical testing sites and collaboration with leading experts in the field. Estimated sales US$4.5M from 2012 – 2014Team Building/Cross Functional Leadership – utilized interpersonal and leadership skills to establish new relationships between various functional groups within our parent company in France and our US group. This led to the creation of a cross-functional project team between the two sites and the creation of several new projects (INR Calibrators & Ready To Use Assays) generating new revenues expected to reach US$5.0M in 3 years.

I utilized my leadership, multi-disciplinary skill set and organizational skills to manage the relocation of the Australian manufacturing facility to Atlanta, US. This required extensive planning, co-ordination and communication to ensure international customers maintained adequate stock of diagnostic reagents during the transition.Project Management – manage cross-functional teams in both Australia and US, coordinate and monitor activities/schedule for manufacturing and quality control departments, logistics, human resource plan, hire staff and manage the contractor selection processWrote and coordinated the Master Validation Plan for the new facility, including Product Validations for all 510k medical devices being manufactured at the new facilityThe facility was inspected and approved by the FDA August 2006. The facility generated revenues of US$3.0M/yr

I utilized my technical proficiencies and strategic planning to optimize existing products and develop new IVD assaysProject Management – devised, monitored and executed a strategic plan to replace a critical raw material as part of a medical device worth 85% of the total division revenue (US$2.5M). Included managing three clinical testing sites, statistical analysis, final validation report and collaboration with major customersCo-wrote FDA 510(k) application for a Factor V Leiden assay. Revenues >US$1.0M/yearProduct Development of OAT Calibrators – responsible for manufacturing/QC processes/final report. Calibrators successfully commercialized in 2004 to global markets (INR Cal Plasmas)

I was responsible for quality control/quality assurance for the operations (In-Vitro Diagnostic division) I utilized my analytical and statistical skills to create a Statistical Process Control system to reduce in-process failure and improve overall pass rates by 15%.

Received national accreditation for Red Cell Serology, Cross Matching, Antenatal testing and Viral marker testingSpecialized in Coagulation Testing (OAT monitoring, FVIII, Fibrinogen) and assay development.

Mba, Business

Post Graduate, Transfusion Science

Honours, Anatomy And Human Biology