JONATHAN YAMUCA
West Orange,NJ
Summary
Dynamic Scientist with extensive experience at Bristol Myers-Squibb, excelling in analytical method development and critical reagent qualification. Proficient in HPLC and Empower 3, I effectively enhance operational quality while training new hires. Bilingual in English and Spanish, I communicate complex concepts clearly and concisely, driving team success and project completion.
Overview
9
9
years of professional experience
Work History
Scientist, QC Critical Reagents
Bristol Myers-Squibb
Summit, NJ
03.2022 - Current
- Execute analytical methods including multicolor flow cytometry for pharmaceutical product characterization
- Oversee critical reagent qualification through antibody titration and data review, adhering to cGMP standards
- Facilitate training for new hires as the Qualified Trainer in flow cytometry assays, evaluating their proficiency in independent assay execution
- Independently develop and document protocols, methods, and reports in compliance with regulatory guidelines
- Collaborate with AS&T on optimizing analytical methods and ensuring timely project completion
- Conduct thorough deviation assessments, identifying root causes and corrective actions to enhance operational quality
- Perform qualification and release of use of new laboratory equipment needed for QC testing, in addition to troubleshooting equipment when needed
- Perform routine calibration as well as weekly and monthly cleaning for all Flow Cytometers
Associate Specialist, QC Sample Management-CAR T
Bristol Myers-Squibb
Summit, NJ
10.2020 - 02.2022
- Support Manufacturing Operations, Materials Management, and QC Laboratory in the receiving, shipping, and dispensing of commercial and clinical patient samples for testing
- Communicate with technical support in providing feedback and solutions towards the improvement of CELabs software to improve efficiency in the logging, change of custody, and in the locating, sample vials
- Conduct clarification of foreign samples in preparation for laboratory testing
- Create and revise work practice and SOPs to department specific tasks
- Handle, sort, and store patient samples in liquid nitrogen storage
- Train and guide a small group of new hires in tasks relating to their job description while providing feedback on their training under GMP guidelines
- Present SOP or work practice to QC Sample management team members on new changes using Power Point
- Coordinate with department directors and management in a virtual meeting for the triage of patient samples during a low yield, in providing Manufacturing Operations the minimum number of vials needed to be produce for testing by QC Laboratory as well as Retain and Back-Up vials when allowed
Scientist, Analytical Development -Chemistry
Bristol Myers-Squibb
Summit, NJ
12.2019 - 10.2020
- Conduct method validation procedures involving linearity, sensitivity, accuracy, repeatability, and intermediate precision
- Perform analytical analysis using HPLC/UPLC/HPLC-CAD and integrate chromatography, process, and report results using Empower 3 software
- Prepare dilutions, mobile phase, media, standards, and working solution
- Execute analytical testing involving, dissolution, assay/impurity, content uniformity, Karl Fischer titration, and excipient compatibility
- Analyze and compare data of samples with varying formulations or subjected to different conditions and observe the trend of their results and determine which is more stable for long term storage and transport of samples
- Provide data on capsules and tablets tested in projects undergoing FDA and European approval
- Record laboratory procedures and data on an electronic notebook (ELN)
Associate Research Scientist, R&D Department
Edenbridge Pharmaceuticals
Parsippany, NJ
11.2019 - 12.2019
- Perform routine analytical testing including dissolution and assay/impurity
- Conduct lab analysis using HPLC and integrate chromatography, process, and report results using Empower software
- Generate accurate and reliable data by following established analytical method and practices for product development in addition to recording, tabulating, summarizing and reporting results
- Generate spreadsheets to calculate data from analytical lab testing using Microsoft Excel
Scientist, Analytical Development – Chemistry
Celgene
Summit, NJ
06.2019 - 10.2019
- Perform routine analytical lab testing such as dissolution, assay/impurity, content uniformity, and forced degradation
- Conduct lab analysis with HPLC/UPLC and integrate chromatography using Empower 3
- Validating analytical testing methods and ensure all analytical testing activities follows GMP regulations
- Generate accurate and reliable data by following established analytical method and practices for product development in addition to recording, tabulating, summarizing, and reporting results
- Identify, evaluate, and implement new analytical methods and quality control strategies for new product development, especially for various modified release dosage forms
- Generate spreadsheets to calculate data from analytical lab testing using Microsoft Excel
- Record laboratory procedures and data on an electronic notebook (ELN)
Chemist, Raw Materials
Lohmann Therapy Systems
West Caldwell, NJ
06.2018 - 10.2018
- Conduct raw material testing following LTS specifications, SOP, or USP monograph
- Perform and complete assigned CAPAs, Change Controls, and Investigation Reports thoroughly within specified deadlines
- Revise and edit control specifications of test materials, testing monographs, and SOPs with the use of SAP/DMS
- Follow cGMP guidelines for all laboratory and quality assurance procedures and documentation
- Monitor batch records to ensure materials are within specification for release
- Perform dissolution on transdermal patches and analyze samples using HPLC
- Test raw materials for compliance in regards to viscosity, pH, titration, color, IR, and other wet chemistry techniques
Scientist, Stability Department
Eurofins (Novartis)
East Hanover, NJ
08.2016 - 04.2018
- Perform dissolution, assay impurity, and disintegration, procedures with controlled substances
- Conduct all drug release and impurity analysis using HPLC
- Analyze and process results of chromatographic data using Empower 3 software
- Prepare dilutions, mobile phase, media, standards, and working solution for each control substance being tested
- Ensure proper documentation is practiced in laboratory notebooks following GMP guidelines as well as executing tasks as per SOP
- Conduct method validation when new process is introduced to test if it is suitable for its intended use
Chemist, Bulk Analytical Department
L’Oréal
Piscataway, NJ
06.2016 - 08.2016
- Performed physical and chemical analysis on finished goods products using basic laboratory procedures which include pH, viscometer, microscope, HPLC, titration, and centrifuge
- Conduct physical tests on finished goods products to determine viscosity, pH, density, microscopic evaluation of emulsion, and color
- Ensure compliance to L’Oréal Standards, GMP and FDA Compliance regarding laboratory documentation
- Coordinating product testing with the other lab members, communicating with contract manufacturers regarding test results or sample submission, and releasing products in SAP
Education
Bachelor of Arts - Chemistry, Biology
Rutgers University
Newark, NJ05.2016
Skills
- MacsQuant
- FACS Canto
- HPLC
- UPLC
- HPLC-CAD
- Chemical weighing
- Dissolution
- Calibration
- Critical reagent qualification
- PH measuring
- Pipetting
- Assay
- Dilution
- FlowJo
- Empower 3
- ELN
- SAP/DMS
- Microsoft Word
- Excel
- PowerPoint
- Public speaking
- Verbal communication
- Written communication
- Bilingual
- English
- Method validation
- Analytical method development
- Spanish
Timeline
Scientist, QC Critical Reagents
Bristol Myers-Squibb
03.2022 - Current
Associate Specialist, QC Sample Management-CAR T
Bristol Myers-Squibb
10.2020 - 02.2022
Scientist, Analytical Development -Chemistry
Bristol Myers-Squibb
12.2019 - 10.2020
Associate Research Scientist, R&D Department
Edenbridge Pharmaceuticals
11.2019 - 12.2019
Scientist, Analytical Development – Chemistry
Celgene
06.2019 - 10.2019
Chemist, Raw Materials
Lohmann Therapy Systems
06.2018 - 10.2018
Scientist, Stability Department
Eurofins (Novartis)
08.2016 - 04.2018
Chemist, Bulk Analytical Department
L’Oréal
06.2016 - 08.2016
Bachelor of Arts - Chemistry, Biology
Rutgers University
Similar Profiles
CHRISTIAN ROSKERCHRISTIAN ROSKER
Medical Director Oncology & Cell Therapies at Bristol-Myers SquibbMedical Director Oncology & Cell Therapies at Bristol-Myers Squibb
Rosetta Dujat des Allimes RuizRosetta Dujat des Allimes Ruiz
Senior Clinical Site Monitor, at Bristol-Myers Squibb CompanySenior Clinical Site Monitor, at Bristol-Myers Squibb Company
Stephanie TrejosStephanie Trejos
Manufacturing Associate at Bristol Myers SquibbManufacturing Associate at Bristol Myers Squibb
Zurwa RazaqZurwa Razaq
Senior Specialist at Bristol Myers Squibb (BMS)Senior Specialist at Bristol Myers Squibb (BMS)
Dorienne GriffithDorienne Griffith
Substitute Preschool Teacher at Neema Pre-School of OrangeSubstitute Preschool Teacher at Neema Pre-School of Orange