As a member of the executive team I provide leadership, management and the vision necessary to ensure that the Company has the proper operational controls, reporting procedures, administrative and people systems in place to effectively grow the organization and to ensure financial strength and operating efficiency. Chief Operating Officer responsibilities include: • Responsible for driving the company to achieve and surpass sales, profitability, cash flow, business goals and… Show more As a member of the executive team I provide leadership, management and the vision necessary to ensure that the Company has the proper operational controls, reporting procedures, administrative and people systems in place to effectively grow the organization and to ensure financial strength and operating efficiency. Chief Operating Officer responsibilities include: • Responsible for driving the company to achieve and surpass sales, profitability, cash flow, business goals and objectives o Set comprehensive goals for performance and growth o Design and implement business strategies, plans and procedures• Motivate and lead a high performance management team; attract, recruit and retain required members of the executive team not currently in place; provide mentoring as a cornerstone to the management career development program• Responsible for measuring the effectiveness of all processes internal and external and provide timely, accurate and complete reports on the operating condition of the company• Collaborate with the management team to develop and implement plans for the operational infrastructure of systems, processes, and personnel designed to accommodate the rapid growth objectives of the organization o Lead in expansion activities (investments, acquisitions, corporate alliances etc.)• Assist, as required, in raising additional capital at appropriate valuations to enable the Company to meet sales, growth, and market share objectives• Establish policies that promote company culture and vision• Lead employees to encourage maximum performance and dedication• Evaluate performance by analyzing and interpreting data and metrics• Act as lead "client-care officer" through direct contact with clients, partners, and vendors• Represent the Company with clients, investors, and business partners Show less

• Assumes leadership role on validation project teams from a quality perspective and provides guidance to ensure that relevant business procedures are being adopted and utilized following the Information Systems Project Delivery Methodology (ISPDM) process• Recommend validation methodology to complex systems based on past experiences and current industry standards utilizing GAMP 5 methodology• Conduct Computerized System Risk Impact Determination (RID) to ensure that the project… Show more • Assumes leadership role on validation project teams from a quality perspective and provides guidance to ensure that relevant business procedures are being adopted and utilized following the Information Systems Project Delivery Methodology (ISPDM) process• Recommend validation methodology to complex systems based on past experiences and current industry standards utilizing GAMP 5 methodology• Conduct Computerized System Risk Impact Determination (RID) to ensure that the project team understands the GxP applicability or other risks including Sarbanes-Oxley (SOX), Security, or Privacy risks associated with all systems• Independently reviews / approves validation documentation for compliance with company policies and government regulations• Assess protocols, specifications, and reports with a focus on cGMP impact, and validation lifecycle requirements • Collaborates with the IS Project Manager to define the quality plan, validation plan, and reporting processes• Authors / reviews / approves departmental SOP’s• Actively participate in departmental staff meetings Show less

• Lead and direct the work of 8 direct reports, establishing the scope of work assignments, experiments, work schedules and deadlines o Support, mentor, and document performance o Train and develop abilities of laboratory personnel• Daily supervision of performance on technical assay transfer, execution, and analysis in various project areas from R&D to Operations and Quality Control o Experiment planning and associated documentation including summary reports o… Show more • Lead and direct the work of 8 direct reports, establishing the scope of work assignments, experiments, work schedules and deadlines o Support, mentor, and document performance o Train and develop abilities of laboratory personnel• Daily supervision of performance on technical assay transfer, execution, and analysis in various project areas from R&D to Operations and Quality Control o Experiment planning and associated documentation including summary reports o Procurement of reagents and equipment o Critically review resulting data and assembly of batch records o Presentation of results to colleagues o Ensure document system is in compliance with ISO standards• Approve data and release lots in inventory control software (Oracle's JD Edwards EnterpriseOne)• Troubleshoot possible lot failure to ensure the integrity of products released or rejected • Assess issues with sustaining released products; communicate and develop strategies for implementing solutions • Evaluate historical data to provide current specifications• Validate QC instruments, procedures, protocols, software and spreadsheets for ISO compliance by authoring, executing, and reviewing validation protocols and master plans of analytical assays• Provide guidance for resolving all CAPAs and CAPA related documents; Deviations, OOS, NCMRs and CAPAs• Establish project codes for financial reporting of man hours worked on specific projects• Write and revise SOP’s and COA’sQuality Control Analyst responsibilities include:• Test multi-well plates coated for a wide variety of assays (phosphoproteins/cell lysates, cytokines and biomarkers)• Transfer assays from R&D to QC• Perform manufacturing reagent QC, incoming materials QC, and intermediate QC on assembled, and uncoated plates• Perform troubleshooting studies to pinpoint failure mode for specific product lots • Execute tests to evaluate the quality and consistency of incoming detection antibodies Show less