RE:Science Officer appointed (formerly Olympus!)This new Chief Science Officer is an excellent addition to TSO3!!!
Not only was he the authority in infection control at Olympus, where he was involved in device development, in charge of clinical affairs, an authority in infection control and device reprocessing, validation testing, worked to represent Olympus at AAMI, etc., was in charge of regulatory validation studies and 510k applications, and gained international experience there, he also worked at Alcon (largest ophthalmologic surgical company in the world) in compliance, regulations, testing, new technologies development, he improved efficiencies in his department >50%! Would someone of his credentials and caliber move to join TSO3 if he did not see the incredibly bright future ahead with this market leader? He is an excellent fit with TSO3 given his PhD training in microbiology and excellent experience in management, infection control, and administration. What a find, Mr. Rumble!!
From his LInked-In profile:
Vice President, Laboratory Operations
Company Name
Alcami Corporation
Dates Employed
Oct 2016 – Present Employment Duration
1 yr Location
Wilmington, North Carolina Area
Operational responsibility for two business units across four sites with more than 350 personnel. Develop and implement strategy for Analytical Testing and Development Services BUs.
Senior Director, Laboratory Operations
Company Name
Alcami Corporation
Dates Employed
Aug 2015 – Oct 2016 Employment Duration
1 yr 3 mos Location
Wilmington, North Carolina
Operational leadership of 120+ scientists to drive pharmaceutical product development and support drug product commercialization.
Unit Head of R&D Safety Microbiology
Company Name
Alcon Laboratories, Inc.
Dates Employed
Sep 2011 – Aug 2015 Employment Duration
4 yrs Location
Fort Worth, TX
• Direct a centralized function comprised of 28 bench analysts and senior scientists who conduct molecular and microbiological research and development in support of pipeline objectives
• Ensure timely and efficient planning and completion of all microbiology testing deliverables
• Ensure compliance to applicable regulations, and utilization of currently approved methods
• As applicable, lead evaluation and implementation of new technologies to address unit requirements
• Ensure timely identification and resolution of issues, and lead problem-solving collaborations with multi-functional teams • Direct allocation of resources in consideration of departmental needs and R&D plans
• Management and development of staff including hiring decisions
• Site Biosafety Officer and Chair of the Biosafety Committee
Key Accomplishments
• Selected to participate in the Novartis M2 Leadership Program
• Restructured the functional unit to align job skills/roles with organizational need and pipeline objectives in less than six months after joining Alcon
• Completed integration of CIBA microbiology laboratory into FTW Safety Microbiology
• Infused unit with high quality talent, filling nine positions in less than a year
• Unit restructuring resulted in a >50% increase in efficiency while significantly reducing annual costs
• Established a Central Operations function within the unit that increased compliance and improved efficiency
Director of Clinical Affairs
Company Name
Olympus
Dates Employed
2009 – Sep 2011 Employment Duration
2 yrs Location
Center Valley, PA
Develop and implement the Clinical Research Strategy for Olympus Medical and Surgical Groups.
Reports to Executive Director of Technical Marketing.
• Founding member of the Clinical Affairs Department with overall responsibility for management of clinical activities in North America
• Interface with Physician Key Opinion Leaders to develop clinical strategy for current and future
products based upon corporate objectives
• Responsible for ensuring that clinical study design and execution supports corporate objectives
• Management of Clinical Affairs budget in compliance with ethical guidelines established for
pharmaceutical and medical device companies
• Developed a procedure for design and execution of Clinical Studies
• Developed a database for management of Clinical Studies with the capability to provide project
information to global personnel
• Monitor clinical studies, including conducting study initiation and routine monitoring visits,
review case report forms, write monitoring reports, and verify conformance to GCPs
• Authoritative expert on Infection Control and device reprocessing for medical and surgical products in North America
• Interface with European and Japanese counterparts regarding product development and device reprocessing
• Director of Microbiology Laboratory responsible for validation testing and device investigations related to Infection Control
• Facilitate contract laboratory testing and manufacturing of cleaning/disinfection products
• Represent interests of global corporation in the development of medical device and reprocessing standards as a participant in AAMI and ASTM, as well as presenting at national and regional professional society meetings
Director, Research
Company Name
Olympus Corporation of the Americas
Dates Employed
Nov 2004 – Feb 2010 Employment Duration
5 yrs 4 mos
• Authoritative expert on Infection Control and device reprocessing issues for medical and surgical products in North America
• Interface with European and Japanese counterparts regarding product development and device reprocessing
• Represent interests of global corporation in the development of medical device and reprocessing standards as a participant in AAMI and ASTM, as well as presenting at national and regional professional society meetings
• Define and execute clinical and laboratory validation testing for new reprocessing equipment
• Report validation studies as part of FDA 510(k) submissions
• Evaluate new reprocessing technologies and equipment for licensing or acquisition
• Develop and publish equipment material compatibility statements for North America
• Education and training of internal personnel and customers
• Support Regulatory Affairs investigations and contribute to Medical Device Reports
• Serve as liaison between manufacturers and parent company regarding requests for endoscope material compatibility testing
• Represent corporation by presenting at national and regional professional conferences
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Education
Penn State University
Degree Name
Master of Business Administration (MBA) Field Of Study
Business Administration and Management, General
Dates attended or expected graduation
1999 – 2003
Pennsylvania State University College of Medicine
Degree Name
PhD Field Of Study
Microbiology and Immunology
Dates attended or expected graduation
1998 – 2003
Villanova University
Degree Name
Master of Arts (M.A.) Field Of Study
Biology
Dates attended or expected graduation
1995 – 1998