Brad Beres Email & Phone Number

United States

Durham, North Carolina, United States

• Coordinated method transfer and validation activities with partners in the US, EU, and Japan ensuring key deliverables meet internal specifications and schedules• Prepared and reviewed technical documents including validation protocols and reports, analytical test procedures, investigation reports and change controls• Worked with external vendors to ensure method transfer and validation deliverables are met• Addressed issues that impacted project goals and proactively determined and presented mitigation strategies• Leveraged leadership, communication and technical skills to effectively establish timelines, identify risks, and deliver relevant project information to a variety of stake holders• Provided GMP documentation to support BLA filings and provide support for related inquiries

Longmont, Colorado, United States

• Accountable for the oversight of three direct reports daily activities, technical development, and annual reviews • Responsibilities include working with commercial manufacturing to schedule laboratory testing and activities, troubleshoot and review assays and associated data, and conduct laboratory investigations• Oversaw analytical method transfers with partner sites and external contract laboratories including drafting of transfer plans, protocols, and reports• Point of contact for raw material testing and release within Commercial QC• Project Manager for QC laboratory startup schedule including instrument qualification, method readiness, consumable readiness, and analytical method transfer tracking• Represented QC labs for both internal and external laboratory inspections and assisted management with audit response writing• Provide technical support for assays performed in QC Commercial labs• Conduct in-depth detailed review of stability, release, and transfer data for accuracy to be used in report writing, method performance monitoring and investigating OOS and OOT test results• Coordinated resource management of personnel and QC space to ensure on-time completion of accelerated timeline projects in a cGMP environment.• Responsible for reviewing, assessing, and reporting test results within QC analytical lab• Work with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and implement corrective actions to improve methods and programs

Chapel Hill, Nc

• Lead small team of QC analysts working on the stability and release testing of gene therapy, large molecule, and other modalities for clinical supply• Responsible for assessing test results in a breadth of analytical methodologies including Compendial test methods, Microbiological test methods, qPCR, and ELISA• Integral component of analytical method validations, qualifications, and transfers with partner sites and external contract laboratories• Represent QC laboratories for regulatory queries and both internal and external inspections• Lead laboratory investigations, deviations and CAPAs utilizing trackwise software• Site QC LIMS Superuser - duties include providing expertise in use of software, training colleagues, and communicating and troubleshooting issues with the LIMS team• Capital Purchasing site representative – duties include managing and securing purchases of equipment and instruments greater than $5000 in value• Leader of the compendial technology team – review current methodologies and procedures to ensure we maintain a compliant laboratory• Mentor for both newly hired / inexperienced colleague

St. Louis, Mo

• Perform analytical testing in both the chemistry and microbiology labs• Maintain / review all related data and records in compliance with cGMPs and quality procedures• Point of Contact for analytical method transfers between Pfizer ARD QC and Pfizer Global Supply Grangecastle, Ireland manufacturing site• Primary role as QC testing lead – duties include scheduling and balancing sample load and release across multiple QC laboratories to ensure testing is completed within pre-determined lead times• Identify and investigate testing issues, OOS results, and/or instrument malfunctions• Work with Quality Assurance to perform root cause analysis and implement CAPAs utilizing Trackwise• Manage contractors daily activities including media preparation and compendial testing• Trained peers on a variety of compendial assays and bioassays

Greater Denver Area

• Conduct Chemistry and Microbiology assays including sterility, mycoplasma, pH, formaldehyde, moisture, and phenol testing• Perform ELISA testing on final container vaccines• Volunteered to lead team that successfully developed and implemented Kinetic Endotoxin and Gel-Clot Endotoxin testing on final products and water samples within QC laboratories• Audit assays, systems, and procedures, identify problem areas and work with Quality Assurance in implementing CAPA’s• Work closely with research and development to develop and improve existing assays

Athens, Ga

• Extensive cell line management work• Virology assays including titrating viruses, COFAL testing, and immunoscreens• Immunochemistry assays such as ELISA’s, UV Peaks, and Radial Immunodiffusion analyses• Microbiology tests such as sterility, mycoplasma, and contaminant identification• Vaccinating dogs and cats, and obtaining blood samples for further testing• Successfully completed training in LEAN manufacturing• Part of team that facilitated and implemented LEAN in the quality control department• Working in a regulated environment and following standard operating procedures• Executing protocols using Kaye validators• Vaccinated and eligible to work with rabies virus and smallpox• Conduct and assist supervisors in design and execution of problem solving protocols using event analyses and other tools• Conduct monthly HSE and Assay audits and implement CAPA's• Maintain and dispose of laboratory hazardous materials• Develop relationships with different departments to transfer and develop new assays• Train incoming and existing employees on assays and SOP’s• Writing and / or updating controlled methods and data captures• Implemented a supply stocking / ordering system to insure supplies are on hand as needed• Place and receive supply orders within site for laboratory use

Bachelor Of Science, Biology

Activities and Societies: University of Georgia Herpetological Society Trout Unlimited

Bachelor Of Science, Wildlife Biology