Dr. Mithun Rajanna

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• Indira PenemetchaIndira Penemetcha

  <ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health

• Jonathan MatulaJonathan Matula

  <ul> <li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li> <li>Department of Agriculture (USDA) and the U.S</li> <li>Department of Homeland Security (DHS)</li> <li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li> <li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li> <li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li> <li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li> <li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li> <li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li> <li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li> <li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li> <li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li> <li>Implemented quality control measures throughout each stage of a project's lifecycle.</li> <li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li> <li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li> <li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li> <li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li> <li>Trained junior staff on best practices for managing multiple projects simultaneously.</li> </ul> at Defense Contracting Activity, LLC<ul> <li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li> <li>Department of Agriculture (USDA) and the U.S</li> <li>Department of Homeland Security (DHS)</li> <li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li> <li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li> <li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li> <li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li> <li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li> <li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li> <li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li> <li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li> <li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li> <li>Implemented quality control measures throughout each stage of a project's lifecycle.</li> <li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li> <li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li> <li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li> <li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li> <li>Trained junior staff on best practices for managing multiple projects simultaneously.</li> </ul> at Defense Contracting Activity, LLC

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