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
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
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
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
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
Similar Profiles
Aishwarya RamanujanAishwarya Ramanujan
Cell Manufacturing Associate at Editas MedicineCell Manufacturing Associate at Editas Medicine
Younis SamaraYounis Samara
Research Assistant at Department of Internal Medicine, Faculty of Medicine, Cairo UniversityResearch Assistant at Department of Internal Medicine, Faculty of Medicine, Cairo University
Marisa MorellMarisa Morell
Program Coordinator at Ellis Medicine Family Medicine Residency ProgramProgram Coordinator at Ellis Medicine Family Medicine Residency Program
Kenny PeñaKenny Peña
Therapist Intern at Multicultural Counseling Center - MCCTherapist Intern at Multicultural Counseling Center - MCC
Elena RomanovaElena Romanova
Babysitter at Family Day CareBabysitter at Family Day Care