Brendan Welch
Germantown
Summary
Quality Control Analyst III with experience in GMP/GLP-regulated biologics testing, specializing in microbiological and analytical assays (qPCR, ELISA, plaque assays). Proven ability to independently execute assays, analyze complex data, and ensure scientific integrity of laboratory results. Strong background in environmental monitoring, cell culture, and quality systems, with demonstrated success in process improvement, training, and cross-functional collaboration.
Overview
11
11
years of professional experience
Work History
Quality Control Analyst III
ABL inc.
Rockville, MD
03.2024 - Current
- Perform advanced analytical testing (qPCR, ELISA, plaque assays) for in-process and final product release, ensuring compliance with cGMP/GLP standards
- Independently execute assays within laboratory scheduling constraints, ensuring reproducibility and high-quality results
- Document detailed observations and analyze complex data sets to support scientific conclusions and product quality decisions
- Perform peer review of laboratory data and batch records to ensure accuracy and Right First Time (RFT) execution
- Lead and mentor junior analysts, providing technical guidance on assay execution, troubleshooting, and GMP compliance
- Generate and trend Environmental Monitoring (EM) data using Excel (pivot tables), supporting regulatory reporting and proactive identification of excursions
- Communicate deviations, interim results, and assay performance to cross-functional stakeholders
- Support internal audit readiness, contributing to zero critical findings over the past year
- Contribute to LIMS validation activities for the EM program, ensuring data integrity and regulatory compliance
- Drive process improvements by revising procedures, reducing material usage and associated costs (~10–15%)
- Develop Excel-based inventory tracking tools to improve forecasting, reduce waste (~15–20%), and ensure material availability
Quality Control Analyst II
ABL inc.
Rockville, MD
07.2022 - 03.2024
- Perform environmental monitoring (Grade A–D) and microbiological testing to support GMP manufacturing of sterile drug products
- Execute microbiological and analytical testing of clean utilities (RODI), including bioburden, endotoxin, and TOC analysis
- Review EM and microbiological documentation for accuracy, completeness, and GMP compliance
- Support deviation investigations and CAPAs, identifying root causes and implementing corrective actions
- Perform Growth Promotion Testing (GPT) for media used in APS and raw material release (TSA, SDA, TSB)
- Qualified visual inspector for fill/finish operations (2 mL, 5 mL, 10 mL vials; batches up to 3,000 units)
- Initiate and support validation of Sievers M9 TOC Analyzer (Turbo Mode), reducing turnaround time by ~66%
Quality Control Analyst II
Astrazeneca
Rockville, MD
04.2022 - 07.2022
- Support environmental monitoring (EM), inventory management, and laboratory operations for R&D and GMP clinical manufacturing activities
- Perform aseptic sampling of viable and non-viable environmental and clean utility samples in controlled environments
- Accurately document and enter QC data in compliance with GMP and internal data integrity standards
- Assist with archival and organization of QC logbooks and records to ensure traceability and audit readiness
- Prepare laboratory solutions, reagents, and standards in accordance with approved procedures and documentation
- Operate and maintain autoclave systems to ensure consistent availability of sterile supplies
- Monitor inventory levels against established thresholds and support timely replenishment of laboratory materials
Manufacturing Associate I
IDT Biologika
Rockville, MD
07.2021 - 04.2022
- Execute upstream, downstream, and fill/finish operations in GMP cleanroom environments (ISO 5, 7, and 8)
- Set up, operate, and troubleshoot bioprocess equipment including bioreactors, chromatography systems, centrifuges, and filling lines
- Support fill/finish operations using semi-automated and automated systems for batches up to 10,000 vials
- Perform in-process testing and complete GMP batch documentation with accuracy and compliance
- Contribute to equipment and cleanroom validation activities, supporting qualification of manufacturing systems
- Train personnel on cleanroom procedures and manufacturing operations
Quality Control (QC) Scientist I- Microbiology
Catalent Pharma Solutions
Harmans, MD
07.2020 - 07.2021
- Conduct environmental monitoring and microbiological testing to support Phase III GMP manufacturing of biologic drug products
- Perform EM sampling in ISO 5, 7, and 8 cleanrooms (viable and non-viable monitoring)
- Execute testing of WFI and clean steam, including bioburden and endotoxin analysis
- Document observations and results in compliance with GMP data integrity standards
- Support aseptic process simulations (media fills) and EM/EMF monitoring
- Collaborate with QA to initiate and complete deviations in a timely manner
- Serve as a qualified trainer for EM, bioburden, and endotoxin testing
Quality Control (QC) Raw Materials Intern
Novavax, Inc.
Gaithersburg, MD
06.2018 - 08.2018
- Support QC testing activities for biologic products in a cGMP environment
- Assist with sample preparation and routine microbiological and analytical testing
- Contribute to SOP revisions and QC documentation updates
- Perform data entry and maintain accurate laboratory records in compliance with GMP standards
- Assist in environmental monitoring and basic laboratory operations
- Support deviation documentation and quality investigations
Manufacturing Intern
Novavax, Inc.
Gaithersburg, MD
06.2016 - 08.2016
- Support cGMP manufacturing of virus-like particle (VLP) and nanoparticle-based vaccine candidates
- Assist in setup, operation, and monitoring of bioprocess equipment, including bioreactors and chromatography systems
- Prepare buffers and solutions to support upstream and downstream processing activities
- Execute GMP documentation and maintain accurate manufacturing records
- Compile and track process data to support manufacturing performance and batch documentation
- Participate in continuous improvement initiatives to enhance process and equipment efficiency
- Assist in deviation investigations and root cause analysis for manufacturing events
Regulatory Affairs Intern
Novavax, Inc.
Gaithersburg, MD
06.2015 - 08.2015
- Support environmental monitoring (EM) and microbiological testing activities in a GMP manufacturing environment
- Perform EM sampling in ISO 5, 7, and 8 cleanrooms, including viable and non-viable monitoring
- Assist with clean utility sampling (WFI, clean steam) and basic microbiological testing (bioburden, endotoxin)
- Contribute to SOP revisions and documentation updates to support compliance and process improvement
- Support deviation documentation and collaborate with QA to ensure timely resolution
- Participate in aseptic process simulations (media fills) and EM/EMF monitoring activities
- Coordinate with cross-functional teams (QC, QA, Manufacturing) to support routine EM operations
Education
Master of Science (M.S.) - Biotechnology, Concentration in Regulatory Affairs
Johns Hopkins University
Baltimore, MD, US05-2027
BA - Biology, Minor Psychology
University of Maryland Baltimore County
01-2020
Skills
Analytical Techniques: qPCR, ELISA, Plaque Assay, Bioburden Testing, Endotoxin (LAL), TOC Analysis, Growth Promotion Testing (GPT)
Microbiology & Environmental Monitoring: Environmental Monitoring (Grade A–D), Aseptic Technique, Microbial Identification, Subculturing, Gram Staining, Media Fills (APS)
Quality Systems & Compliance: cGMP, Good Documentation Practices (GDP), Deviations, CAPA, Change Control, Audit Readiness
Laboratory Systems & Data Analysis: LIMS, Data Analysis & Trending (Excel, Pivot Tables), Data Integrity (ALCOA)
Equipment & Validation: Instrument Qualification & Validation, TOC Analyzer (Sievers M9), General Laboratory Instrumentation
Process Improvement: Lean Six Sigma, Continuous Improvement, Root Cause Analysis
Analytical & Biosafety Assays: qPCR, ELISA, Plaque Assay, Bioburden Testing, Endotoxin (LAL), TOC Analysis, Growth Promotion Testing (GPT)
Cell Culture & Aseptic Techniques: Mammalian cell culture (Vero, CHO, CV-1), Aseptic Processing, Media Fills (APS), Environmental Monitoring (Grade A–D)
Microbiology: Microbial Identification, Subculturing, Gram Staining, Clean Utility Testing (WFI, RODI, Clean Steam)
Quality Systems & Compliance: cGMP, GLP, Good Documentation Practices (GDP), Deviations, CAPA, Change Control, Audit Readiness
Data Analysis & Laboratory Systems: Data Analysis & Trending (Excel, Pivot Tables), LIMS, Data Integrity (ALCOA), Electronic Documentation Systems
Equipment & Instrumentation: qPCR Systems, TOC Analyzer (Sievers M9), General Laboratory Equipment, Instrument Qualification & Validation
Process Improvement & Leadership: Root Cause Analysis, Continuous Improvement, Lean Six Sigma, Training & Mentorship
Regulatory Frameworks: USP , USP , EU GMP Annex 1
Timeline
Quality Control Analyst III
ABL inc.
03.2024 - Current
Quality Control Analyst II
ABL inc.
07.2022 - 03.2024
Quality Control Analyst II
Astrazeneca
04.2022 - 07.2022
Manufacturing Associate I
IDT Biologika
07.2021 - 04.2022
Quality Control (QC) Scientist I- Microbiology
Catalent Pharma Solutions
07.2020 - 07.2021
Quality Control (QC) Raw Materials Intern
Novavax, Inc.
06.2018 - 08.2018
Manufacturing Intern
Novavax, Inc.
06.2016 - 08.2016
Regulatory Affairs Intern
Novavax, Inc.
06.2015 - 08.2015
BA - Biology, Minor Psychology
University of Maryland Baltimore County
Master of Science (M.S.) - Biotechnology, Concentration in Regulatory Affairs
Johns Hopkins University