BRIAN NAZAIRE
Tewksbury,United States
Summary
Primary work in analytical PCR testing for release and stability samples for Quality Control purposes. Currently in a MBA Program at Southern New Hampshire University. Efficient in authoring, revising, and submitting SOPs, equipment and pipette validation, audit record reconciliation, CAPAs and change controls. Early biotech experience included purification techniques such as UFDF, Chromatography, tangential flow filtration and final filtration for downstream/upstream processes in clean room GMP environments.
Overview
8
8
years of professional experience
Work History
Quality Control Scientist II
Pfizer
11.2023 - 06.2025
- Performed analytical testing for release and stability samples using qPCR and ddPCR techniques, ensuring accuracy, sensitivity, and full compliance with regulatory and quality standards.
- Conducted scheduled maintenance, calibration, and troubleshooting of the Applied Biosystems 7500 Real-Time PCR System, ensuring optimal performance and minimizing downtime.
- Executed validation and stability studies for drug substance and drug product samples in accordance with GMP/GLP requirements.
- Performed equipment qualifications and pipette validations, ensuring reliability and adherence to laboratory quality standards.
- Authored, revised, and submitted Standard Operating Procedures (SOPs) to support streamlined workflows and regulatory compliance.
- Completed audit record reconciliation, ensuring data integrity and readiness for internal and external inspections.
- Managed data entry, documentation, and record control, maintaining complete, accurate, and traceable laboratory records.
- Initiated and contributed to CAPA (Corrective and Preventive Actions) and change control processes to address deviations and improve operational efficiency.
- Conducted in-depth data analysis to identify trends and insights, supporting scientific advancement and process optimization.
- Negotiated with suppliers to secure high-quality materials at reduced costs, optimizing budget utilization.
- Performed complex troubleshooting and contributed to assay and instrumentation improvement initiatives, accelerating issue resolution and enhancing laboratory performance.
- Reported, reviewed, and tracked assay data through LIMS, ensuring robust data traceability and compliance.
- Served as a 5S and Safety Committee Representative, promoting a clean, organized, and safe laboratory environment.
Technical Associate, Clinical Manufacturing
Pfizer
03.2022 - 11.2023
- Supported cGMP production of Phase I/II clinical drug substance for Pfizer’s biotherapeutics portfolio.
- Revised and updated Standard Operating Procedures (SOPs) to improve clarity and compliance.
- Performed batch record auditing, sample management, data tracking, and documentation filing to maintain audit readiness.
- Conducted downstream processing using UF/DF, chromatography, tangential flow filtration, and final filtration techniques.
- Executed upstream bioprocessing activities including microorganism isolation, inoculum development, media preparation, inoculation, incubation, and harvest.
- Contributed to successful small-scale mRNA and saRNA manufacturing campaigns.
- Operated and maintained Solo VPE, pH meters, and UV spectrophotometers to ensure accurate analytical measurements.
- Served as a Safety Committee representative, promoting proactive safety measures within GMP processing suites.
- Supported large-scale molecule campaigns, including ChoMAb, IL4/13 TSLP, and IL4/33.
Manufacturing Quality Technician
Lantheus Medical Imaging
01.2021 - 03.2022
- Performed material transfer, preparation, batching, filling, inspection, and other ancillary operations for pharmaceutical manufacturing.
- Independently entered, verified, and reviewed data to ensure accuracy, completeness, and compliance.
- Demonstrated strong understanding of computer-controlled automated production equipment and its operation.
- Executed inventory movements and material transactions within the ERP system.
- Communicated effectively with Quality Control and Microbiology teams to support manufacturing workflows.
- Coordinated procurement of required materials from the warehouse to maintain efficient production operations.
- Operated manufacturing equipment to support protocol validations and engineering studies.
Contractor
Randstad At Lantheus Medical Imaging Site
07.2020 - 01.2021
- Performed material transfer, preparation, batching, filling, inspection, and related support operations for pharmaceutical manufacturing in a cGMP environment.
- Applied cGMP regulations to routine tasks, ensuring compliance, product quality, and consistent documentation standards.
- Collaborated effectively with team leads and managers, demonstrating strong ability to follow direction and integrate coaching into daily operations.
- Actively upheld Lantheus core values—Accountability, Quality, Efficiency, Customer Service, and Safety—through dependable work practices and attention to detail.
Direct Care Staff
Department Of Industrial Services
06.2017 - 03.2020
- Focused on career planning and crisis intervention for individuals with disabilities.
- Tracked development and helped devise plans for further progressions.
- Maintained data integrity and document accountability.
- Data entry and management.
- Project planning.
Education
Master of Business Management -
Southern New Hampshire
Hooksett, NH01-2027
Bachelor of Science - Biology
University of Massachusetts Amherst
Amherst, MA05.2020
Skills
- PCR and molecular biology techniques
- Data entry and record management
- Chemical reagent preparation
- SOP revision
- QPCR / ddPCR techniques
- Public speaking proficiency
- Good Documentation Practices (GDP) Good Manufacturing Procedures (cGMP), and OSHA
- Clean Room environment experience
- Microsoft Word / Excel proficiency
- Lifelong Learner
- Instrument Calibration
- Method validation
Details
- Tewksbury, Massachusetts
- United States
- 978-631-9257
- Brian.nazaire@gmail.com
Timeline
Quality Control Scientist II
Pfizer
11.2023 - 06.2025
Technical Associate, Clinical Manufacturing
Pfizer
03.2022 - 11.2023
Manufacturing Quality Technician
Lantheus Medical Imaging
01.2021 - 03.2022
Contractor
Randstad At Lantheus Medical Imaging Site
07.2020 - 01.2021
Direct Care Staff
Department Of Industrial Services
06.2017 - 03.2020
Bachelor of Science - Biology
University of Massachusetts Amherst
Master of Business Management -
Southern New Hampshire