Michael Silvey Email & Phone Number

Portland, Or, Us

Hillsboro, Oregon, United States

Hillsboro, Oregon, United States

Hillsboro, Oregon, United States

Portland, Oregon Area

Basel Area, Switzerland

(Rotation 3 of ORDP)- Responsible for transferring the strategy and managing the execution of 4 team members for a global initiative, Optimization of QC Stability Network, to ensure implementation and strict timelines were achieved. Initiative expected to reduce network QC spending by XX million CHF annually. - Led Active Stability Study Simplification Workstream where the team developed, piloted, and implemented a global program to evaluate all molecules, SM and LM, active stability studies and simplify testing points. - Facilitated X workshops to understand current state and drive decisions reducing the cost of testing by an estimated X million CHF for 4 products. Led cross-functional subteam to evaluate case studies and pilots to develop implementation to network portfolio. - Led cross functional Outsource Evaluation subteam where internal SMEs worked to develop internal requirements for transfer, translate requirements into external requests for quotation (RfQ), and evaluate / propose business case. Required facilitating three rounds of quoting 15 Contract Laboratory Organization (CLOs) and 5 divested manufacturing sites or Contract manufacturing Organizations (CMO). - Facilitate procurement efforts surrounding outsourcing Quality Control execution for a Phase II Biologic molecule. Required translating internal needs into external expectations, obtained quotes from five CLOs, and advised team on final selection. Led the contracting and negotiation efforts to finalize the outsourcing.

- Led the data and lab sub team during Quality Investigation that shut a $XXX M drug product fill line down for 30+ weeks. Managed the execution of more than 10 diagnostic tests and lab operations to support isolation and analysis of more than 300 particulate samples. - Enhanced MSAT lab capabilities through development and standardization of four new filtration analysis methods. - Oversaw lab operations and the training activities of 10 technicians while executing particle identification utilizing the Rap.ID Particle Explorer technology. - Designed 10+ diagnostic tests to isolate equipment and interpreted data to inform decisions surrounding root cause and return to service.- Executed technical assessments for discrepant events (DMS) and change records.- Provided technical support for clinical and commercial fills where special accommodations were needed.- Facilitated / Led L2 DP RAPID where filling operations would present process data and escalate the need for additional resources to ensure continuous improvement and minimal downtime.

South San Francisco

- Evaluated current business processes for production of Annual Quality Product Review reports through a Lean Six Sigma Green Belt project. - Formulated and proposed path to future business state while implementing change management strategies to empower the report authors to own their improvement process and implement continuous improvements. - Lead 3 core teams at differing hierarchal positions in the organization to allow for implementation and sustainability of a "bottoms up", Lean, improvement program. - Facilitated and managed 2 improvement projects and 3 Kaizens to initiate the departments Lean Six Sigma transformation. Improvements led a 33% reduction in lead times and a 70% reduction in defects per report. - Lean Six Sigma Green Belt Certified

Hillsboro, Oregon

-Designed and implemented process improvements to reduce non-value added business processes. Improvements expected to significantly reduce time technicians are documenting work and notation errors while increasing throughput through the center. -Evaluated and analyzed North American Freeze Thaw Tank life cycle data and tank movements to influence improvements on network inefficiencies and reduce number of future tank purchases.

Hillsboro, Oregon

-Evaluated the efficiency of the North American Freeze Thaw Tank Fleet and formulated solutions to specific portions of the tank life cycle to reduce handling, processing, and idle times. The proposed solutions were evaluated based on predicted savings to the company and potential return on investments when necessary. Implementation of cycle time reduction is expected to save $XX Million in 2017 by reducing life cycle by 28 days.-Derived process performance measurements for key cross functional teams throughout HTO and the network. Designed and presented dashboards for SMART teams to allow auto calculation of metrics on a common simplified site. Evaluated efficiency within the Tank Management Center and proposed ideas to better the process. -Designed and recommend two improvements to the freeze thaw tank fleet to simplify the process, reduce the cost per life cycle, and maintain the integrity of the tank over longer periods of time. Required consulting with the Tank Management mechanics, production, quality, procurement, and arranging meetings with outside vendors to develop prototypes and compare costs of products. Specifically, designed a dip tube process improvement that has been quoted to save $XXXK in 2017.

Corvallis, Oregon

- Connected students and faculty with the 175 companies of OBA. This was accomplished by consulting and educating students and staff about the growing fields of bioscience and biotechnology, as well as, promoting student internships and involvement with companies across Oregon. - Coordinated the Research Pavilion at the annual OBA conference where 20 faculty and graduate students from Oregon State presented their research to over 50 investors and 100 representatives from OBA’s companies. - Organized and communicated to allow successful weekly meetings with industry leaders, Oregon State faculty, department heads, and University officials.

Corvallis, Oregon Area

- Developed a club to connect students with the Bioscience Industry. Mission of the organization is to guide students in learning how to network with key industry executives and understand the steps needed to succeed in this growing field. - Led weekly meetings with students, as well as, meetings with industry representatives and OSU faculty, managed financials of the club, and coordinated large-scale industry events (over 100 students for all three events).

- Led student research group to optimize data and provide customers with proper, simplified, operating procedures. Responsible for creating and executing standard operating procedures with the EssenEx-100 reactor to conduct research on several botanicals. Analyzed data to help create a simplified process that would cost the company less in manufacturing costs while giving customers better products. - Communicated with customers from across the world to eliminate problems with extraction techniques as they arose. I was able to alleviate over 75 customer problems over the course of a year and a half, which often led to investigations of the reactor to find specific answers to their problems. - Handled sales of the devices at large fairs including the Oregon State Fair in Salem where we sold a record amount for the company. I sold 60 reactors over the course of two weeks at the state fair. - Developed a new condensing unit which provided valuable experience with standard operating procedures, steam distillation techniques, thin layer chromatography, optimization of processes, and business operations to allow for operational excellence both in the lab and in the final product. Trained 12 students over the course of a year and a half as they joined our team.

Oregon State

- Led the judicial portion of the largest club on campus dealing with 50 high profile cases which lead to implementation of programs that lead to improved quality of life, increased student involvement, and promoted student involvement. Organized meetings and programs with professionals in the Corvallis community to work on health and professional programs to better the chapters and students in our Greek community.

- Conducted preliminary research for ground-breaking technologies in the Bioscience field. Also helped to conduct market analyses to determine potential for research and development. Allowed for development of technical analytic skills due to an introduction into market analysis strategies.

Portland, Oregon

- Responsible for providing comprehensive environmental health and safety training and orientation for trade contractors associated with the construction of a $300 million dollar semiconductor manufacturing building. Trained 500 trade workers in the key aspects of project management and safety at one of the largest sites in Oregon.

Mba - Biotechnology Enterprise And Entrepreneurship, Biotechnology Management, 3.8 / 4

Bachelor Of Science, Biological Engineering

Activities and Societies: OSU College of Engineering Leadership Academy, Vice President Regulations- Interfraternity Council, Founder.

High School Diploma