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

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

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

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

Bachelor Of Science, Biology

Activities and Societies: University of Georgia Herpetological Society Trout Unlimited

Bachelor Of Science, Wildlife Biology