BRYAN MCLAUGHLIN
Brighton,MA
Summary
Experienced Senior Quality Control Specialist with 9+ years in the biotech/pharmaceutical sector. Specializes in data integrity and quality management, ensuring GxP compliance, conducting risk assessments, and developing analytical methods. Adept at maintaining high standards in laboratory management and cross-functional collaboration. Dedicated to advancing quality control processes and driving innovation in sample management workflows.
Overview
9
9
years of professional experience
Work History
Senior Quality Control Specialist Sample Management
Editas Medicine
Waltham, MA
03.2024 - Current
- Streamlined sample submission processes by fostering strong relationships with internal partners and external testing facilities
- Championed data integrity by meticulously tracking and comparing testing data against established specifications
- Maintained meticulous sampling and testing records in strict adherence to cGMP regulations, developing exceptional documentation skills for clarity and compliance
- Progressed towards independently generating accurate and timely Certificates of Analysis (COAs), demonstrating a strong grasp of data analysis and QC specifications
- Collaborated effectively with cross-functional teams (Manufacturing, Engineering, QA) to ensure adherence to the Quality Management System (QMS) and efficiently address quality issues
- Consolidated and standardized sample, shipment, and assay data management through a centralized system
- Foster strategic partnerships with testing facilities and internal teams to optimize sample management workflows and enhance operational efficiency
- Lead data integrity initiatives through systematic tracking and validation of testing results against established quality specifications
- Spearhead implementation of centralized data management system to streamline sample tracking and testing documentation processes
Senior Associate Scientist
Candel Therapeutics
Needham, MA
11.2022 - 12.2023
- Led the design, equipment selection, and implementation of safety protocols, establishing a cutting-edge analytical laboratory focused on quality excellence
- Led the setup, calibration, and validation of analytical instruments, guaranteeing the accuracy and precision of critical assays
- Established and managed comprehensive QC processes, driving consistent quality standards.
- Developed and optimized Cell based assays, contributing to the successful validation of crucial processes.
- Performed a thorough risk assessment to identify potential QC challenges associated with the new laboratory setup, mitigating risks through appropriate control measures
- Developed and documented detailed SOPs for all newly established analytical methods, and updating existing methods.
- Streamlined laboratory workflows through strategic equipment selection and systematic validation procedures, reducing analytical testing turnaround time
- Directed end-to-end implementation of laboratory safety protocols and documentation systems, establishing robust quality management framework
Associate Scientist
Merck
West Point, PA
10.2017 - 10.2022
- Executed non-GMP and GMP analytical assays, independently developing and optimizing procedures to achieve superior quality results
- Ensured the highest quality of analytical data through meticulous recordkeeping and clear, concise documentation
- Championed cross-functional collaboration to ensure quality throughout the product lifecycle, working effectively with analytical, formulation, and manufacturing teams
- Identified and communicated atypical and out-of-specification test results promptly, allowing for timely corrective actions to maintain quality control
- Developed and implemented control strategies to mitigate potential quality risks associated with new analytical cell based assays.
- Performed routine audits of laboratory practices and procedures to ensure adherence to cGMP regulations and internal quality standards
- Led a team of junior analysts in proper sample handling, data analysis techniques, and assay processes.
- Led cross-functional initiatives between analytical and processing departments to streamline product quality assessment workflows
- Developed solutions for out-of-specification results through systematic investigation and root cause analysis, ensuring product quality standards
Analytical Analyst
Alliance Pharma
Malvern, PA
10.2016 - 10.2017
- Extracted biological samples for precise analysis, enhancing data accuracy
- Coordinated with federal bodies to align drug testing, ensuring compliance
- Calibrated lab instruments, maintaining optimal performance for all tests
- Developed tailored HPLC MS/MS methods, improving study-specific results
- Analyzed samples with HPLC MS/MS, optimizing noise-to-signal for clarity
- Conducted complex pharmaceutical analyses, documented findings meticulously, and maintained strict compliance with industry regulations
- Implemented rigorous quality control measures for sample handling, resulting in consistent and reliable analytical outcomes
Education
Bachelor of Science - Biotechnology and Molecular Biosciences
Rochester Institute of Technology
Rochester, NY05-2016
Skills
- Analytical Method Development
- Quality Control
- GMP Compliance
- GLP Compliance
- Data Integrity
- Laboratory Management
- Risk Assessment
- SOP Development
- Cross-Functional Collaboration
- Data Analysis
- Process Improvement
- Sample Management
- Assay Development
- Workflow Optimization
- Analytical Instrumentation
- Quality Management
- Data Management
- Documentation Skills
- Laboratory Automation
- Statistical Analysis
- Analytical Troubleshooting
- Quality Improvement
Timeline
Senior Quality Control Specialist Sample Management
Editas Medicine
03.2024 - Current
Senior Associate Scientist
Candel Therapeutics
11.2022 - 12.2023
Associate Scientist
Merck
10.2017 - 10.2022
Analytical Analyst
Alliance Pharma
10.2016 - 10.2017
Bachelor of Science - Biotechnology and Molecular Biosciences
Rochester Institute of Technology
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