PURPOSE:

• In this role, you will manage the testing laboratory and 2 employees: Beacon Diagnostics Laboratory (BDL), a CLIA-certified reference laboratory specializing in (1?3)-ß-D-glucan and serum galactomannan (GM) antigen testing to support the diagnosis of Fungal Disease
• In this role, you will also oversee BDL testing activities and related study documentation in support of the Research & Development, Product Development and Clinical Development groups.

GENERAL RESPONSIBILITIES:

• Responsible for ensuring that personnel, methods, and standard operating procedures comply with FDA, ISO 13485, CMS CLIA (along with applicable state department of health regulations), and other applicable national and global requirements.
• Manage, mentor, coach, and develop direct staff to meet and exceed individual, departmental and divisional goals ensuring alignment with corporate objectives.
• Oversee customer interactions including contracts, communication of testing results, and responses to inquiries and inspections.
• Oversee the budget and expenses for BDL
• Participate in strategic planning for future business growth.
• Oversee implementation of new training, compliance, software programs, and improvement initiatives.
• Supervise the verification and validation of new testing assays for addition to BDL Testing Service Menu.
• Establish departmental metrics for sample testing, trend results and other metrics e.g., measures of customer satisfaction and report to management.
• Conduct laboratory experiments and studies according to approved protocols and Standard Operating Procedures (SOPs) in support of the Research & Development, Product Development and Clinical Development groups.
• Collaborate in creating new SOPs, protocols for studies, verifications, and validations.
• Analyze laboratory results and prepare study reports.
• Understand and follow Design Control requirements for the development of new products and processes
• Participate in cross-functional activities.
• Maintain records in accordance with CLIA and Quality Assurance guidelines.
• Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products.
• Other duties as assigned.