Transition from a biochemist role into a proficient perfusionist by utilizing my strong foundation in biotechnology to manage and operate heart-lung machines with precision and care. Committed to applying my expertise in biochemical processes and patient safety to ensure optimal cardiovascular support during surgeries, fostering better patient outcomes through meticulous attention to detail and a collaborative approach within the surgical team.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Nuclear Medicine
Lawerence Berkeley Laboratory
Berkeley
02.2025 - Current
-Assist in conducting experiments for the development of radiopharmaceuticals.
- Help in studying the kinetics and distribution of radioactive substances in biological systems.
- Work alongside multidisciplinary teams to support imaging technology advancements.2. **Data Management:**
- Assist in the collection and analysis of data from nuclear imaging studies.
- Help interpret results and prepare preliminary reports and presentations.
Regulatory and Safety Compliance
- Ensure adherence to regulatory standards and safety protocols in research activities.
- Assist in preparing the necessary documentation for compliance and reporting.
ColCollaboration and team support:
- Work under the supervision of senior researchers and scientists.
- Collaborate with team members to facilitate smooth research operations.
Learning and Development
- Engage in learning opportunities to stay updated with advancements in nuclear medicine.
- Participate in training sessions to enhance skills and contribute more effectively.
Quality Control/Quality Assurance Analyst
Eyenovia
Redwood City
04.2023 - 12.2024
Perform complex tests and analyze to assure that products comply with established specifications.
Complete record of inspection results, acceptance, rejection and disposition for entry into log books, batch audit records, and/or computer databases.
Work with applicable departments to ensure that calibration and maintenance are performed as required by applicable procedures.
Support Quality Systems, CAPA, audits, & change controls
Support equipment validation, calibration, maintenance, and troubleshooting
Monitor the disposition of all issued nonconformance reports.
Monitor the progress and effectiveness of the project quality management system.
Recommend and implement improvements when required.
Coordinate all QA/QC activities with the site QC manager.
Initiate and investigate deviations, CAPA’s, NCMR’s.
Write and revise QC SOP’s, protocols & reports.
Environmental Monitoring Viable and Non-Viable
Sterility testing
Endotoxin
Quality Control Microbiologist
AmplifyBio
San Francisco
02.2021 - 03.2023
Perform routine and non-routine microbiological test, assisting in covering in-process, lot release, and stability purposes.
Contribute substantively and assist in training other QC associates.
Conduct work in compliance with FDA Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Code of Federal Regulations (CFR), and specific Amplify-Bio QC policies.
Maintain and operate the QC laboratory, contributing to laboratory maintenance and operational systems.
Communicate clearly and concisely, both verbally and in written reports. Contribute to the revision of laboratory procedures as necessary for the QC department's operations- via SOP’s.
Manage QC testing to support GMP production, raw material testing, and standalone QC testing projects.
Interpret analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.
Perform water monitoring consisting of bioburden and endotoxin testing.
Perform compressed gas monitoring consisting of viable airborne, non-viable particulate, moisture, and hydrocarbon testing.
Perform sterility testing on purification of drug product.
Perform growth promotion
Perform total organic carbon extraction using a carbon analyzer.
Assist with CAPA’s and Deviations
Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action. Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
Assist with Root Cause Analysis (RCA) defined the problem/deviations. Analyze what I see happening, and identify the precise symptoms so that you can form a problem statement. Gather data, Identified main factors for contribution, and determined root causes.
Endotoxin, Sterility, Environmental Monitoring, Growth Promotion, and Mycoplasma.
Research Assistant (Intern)
Texas Southern University
Houston
01.2020 - 12.2021
I worked alongside researchers and received training in using specialized instruments and techniques to conduct research, develop, and produce chemical products and processes.
Aided chemists in performing lab assessments, conducted tests, and utilized analytical skills to interpret complex data, compile results, prepare reports, and present findings to team members.
Followed lab protocols and procedures while setting up lab equipment and correctly preparing chemical solutions.
Gather, organize, and maintain data related to ongoing research projects.
Research and review existing studies and publications relevant to the current research focus.
Process and interpret data using statistical tools and techniques, helping to draw meaningful conclusions.
Biochemist
Cardinal Health
Houston
04.2020 - 02.2021
Manufacture radioactive isotopes and perform quality control testing for pharmaceuticals including Vizamyl for treating Alzheimer's and Fluorodeoxyglucose (FDG) for treating cancer
Conduct testing to verify products are produced in compliance with quality standards and are in compliance with cGMP and GMP manufacturing timelines
Support laboratory investigations, perform impact assessments, conduct root cause analysis, and implement corrective actions in collaboration with quality assurance and other departments to resolve issues
Follow all organizational policies and procedures to work in an ISO 7 cleanroom to produce product and patient vials used in drug production
Leverage time management and organizational skills to coordinate daily production runs based on customer and pharmacy requirements
Accurately complete documentation, perform administrative tasks, and update daily production and maintenance records to ensure production goals are achieved
Devise and implement process improvements to promptly resolve complex issues in a high-volume and deadline-driven environment.
Qualification and Validation
In-depth understanding of some or most of the industry-standard analytical techniques and technologies ( HPLC/UPLC, ELISA)
Root Cause Analysis defined the problem/deviations. Analyze what I see happening, and identify the precise symptoms so that you can form a problem statement. Gather data, identified main factors for contribution, and determined root causes.
Perform routine and non-routine biochemical test methods for cellular drug therapy product manufacturing, covering in-process, lot release, and stability purposes.
Suitability testing
Sterility Testing
Biomedical Technician
American RedCross
Houston
01.2016 - 01.2019
Leveraged analytical and organizational skills to perform data entry and operate computer programs associated with component production, labeling, storage, and shipping.
Followed company procedures while quarantining and disposing of unacceptable products and samples.
Conducted quality control tests with blood group reagents and confirmed antigens were present in hemoglobin before distribution.
Followed inventory management procedure during the manufacturing and shipping process.
Education
Bachelor of Science - Biology
Texas Southern University
Houston, TX
Master of Science - Biotechnology
Morehouse School of Medicine
Atlanta, GA
Skills
Radiopharmaceutical development, Data analysis, Regulatory compliance, Quality control, Risk assessment, Statistical analysis, Laboratory protocols, Team collaboration, Equipment validation, Process improvement, Communication skills, Problem solving, Technical writing, Nuclear medicine support, Training and development, Biology, Microbiology, Molecular Biology, Biochemistry Cell Biology/Culture, TLC, Gel Electrophoresis, Microscopy, Biochemistry, High-Performance Liquid Chromatography (HPLC), Immunoassays, PCR, Good Laboratory Practices (GLP), ELISA, Western Blot, Suitability purification testing, Environmental monitoring, FDA Regulations, GLP, CGMP Regulations, Aseptic techniques, Statistical Analysis, Bioburden, Validation, Pharmaceutical Microbiology, Problem-Solving, Fishbone, Communication Skills, Interpersonal Skills, Analytical Skills, Quality Assurance Lot release, and Stability Purposes, Endotoxin, Growth Promotion, In process monitoring, CAPA, Deviations, Veeva Vault, Chromeleon, Excel, Good manufacturing practices (GMP), Good Documentation Practices (GDP) Root Cause Analysis (RCA), Time management, Endotoxin, Sterility, and Mycoplasma Proficient organization skills OOS
Certification
Bridge to Health Informatics, Morehouse School of Medicine
Bridge to Biotechnology, Morehouse School of Medicine
Operations Manager – Energy Sciences Area at Lawrence Berkeley National LaboratoryOperations Manager – Energy Sciences Area at Lawrence Berkeley National Laboratory