BARKAT UL AIN
Bensalem,PA
Summary
Scientist with commitment to maintaining high standards in quality control. Adept at ensuring compliance with regulatory requirements and enhancing product integrity. Focuses on collaborative teamwork and adapting to changing needs to achieve consistent results. Known for problem-solving skills and thorough data analysis.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Senior QC Associate, Analytical
Abzena
Bristol, PA
07.2023 - Current
- Lead method development, phase-appropriate validation, and method transfer for large-molecule programs (ADCs, AOCs, Linker Payloads) using U/HPLC, UPLC, AEX, RP, SEC, HIC, ELSD, CE-SDS, and CIEF in a GMP analytical laboratory.
- Conducting HPLC and GC analysis including sample preparation, standard and mobile-phase preparation, instrument setup, system suitability, data acquisition, results review, and chromatographic troubleshooting.
- Author and independently manage method validation protocols and reports, ensuring compliance with client requirements and cGMP standards.
- Serve as subject matter expert for HPLC/UPLC and Empower systems.
- Leading and coordinating laboratory investigation activities with QA which includes system suitability failures, method/protocol deviations and OOS/OOT results, implementation of CAPA and cGMP/regulatory audits.
- Lead and mentor junior analysts on QC procedures, documentation standards, and regulatory compliance.
- Communicate directly with clients on test plans, change controls, and analytical reports, translating complex technical results into clear written and verbal updates.
Assistant Scientist
Kenvue (Johnson & Johnson)
Guelph, ON, Canada
04.2022 - 07.2023
- Performed Process Validation Studies, stability studies, and U/HPLC-based analytical testing for OTC products in a GMP laboratory setting.
- Maintained accurate and compliant analytical documentation, ensuring data integrity and ALCOA+ principles throughout sample preparation, testing, calculations, and reporting.
- Designed ELN templates and improved LIMS data traceability, strengthening lab compliance and documentation accuracy.
- Performed equipment troubleshooting and routine maintenance for HPLC and GC systems, investigating issues related to system suitability, peak shape, retention time, pressure, baseline, and other chromatographic performance parameters.
Scientist II
Thermo Fisher Scientific
Mississauga, ON, Canada
01.2021 - 04.2022
- Executed routine and troubleshooting analyses using HPLC, GC, dissolution, FTIR, particle size analysis, pH and viscosity instrumentation.
- Led all R&D analytical activities and provided technical directions and expertise throughout the entire drug development process including analytical method development, method validation, method transfer formal and informal stability studies as well as cleaning validation, calibration and troubleshooting activities.
- Developed and validated U/HPLC methods for assay, dissolution, and degradation product analysis, applying strong analytical problem-solving to method troubleshooting.
- Provided technical guidance to junior analysts, supporting a small-team environment focused on continuous laboratory improvement.
Scientist I
Thermo Fisher Scientific
Mississauga, ON, Canada
01.2019 - 01.2021
- Performed comprehensive QC analytical testing of raw materials, APIs and finished products in accordance with approved procedures, specifications, USP requirements, and cGMP practices.
- Performed physical and chemical testing — including U/HPLC and dissolution — on raw materials, in-process samples, and finished products in a GMP/GLP laboratory, achieving a Right First Time (RFT) error rate below 5%.
- Performed bench testing and wet chemistry analyses for APIs, raw materials, intermediates, and finished pharmaceutical products, ensuring compliance with established specifications.
- Maintained rigorous data documentation and SOP adherence, demonstrating detail-oriented analytical practice in a fast-paced environment.
Analytical Chemist
Covar Pharmaceuticals
Mississauga, ON, Canada
04.2018 - 01.2019
- Developed and executed stability and analytical studies, including method development, to support pharmaceutical regulatory submissions.
- Maintained and calibrated laboratory equipment and authored SOPs to ensure GMP compliance.
- Supported lab startup activities and established testing protocols for high-potency products.
Education
Ph.D. - Chemistry
M.Sc. - Chemistry
B.Sc. - Chemistry
Skills
- Analytical Techniques: U/HPLC, Dissolution & Disintegration Testing, Particle Size Analysis, UV-Vis Spectrophotometry, FTIR, Karl Fischer (KF), CE-SDS, iCIEF, GC, LCMS
- Method Development & Validation: Method development, Phase-appropriate validation, Method transfer, Instrument qualification
- Investigations & Compliance: Deviation Management, OOS/OOT investigations, CAPA, Change Controls
- Leadership & Communication: Leading and mentoring small technical teams, training junior analysts, client interaction, strong written and oral communication
- Software: Empower 3, LIMS, ELN, Agilent ChemStation, MS Office
- Laboratory skills
- Quality metrics
- Quality management systems
- Test method validation
- Data interpretation
- Quality processes
Certification
- GMP Certified
- TRIEC Mentorship Award
Timeline
Senior QC Associate, Analytical
Abzena
07.2023 - Current
Assistant Scientist
Kenvue (Johnson & Johnson)
04.2022 - 07.2023
Scientist II
Thermo Fisher Scientific
01.2021 - 04.2022
Scientist I
Thermo Fisher Scientific
01.2019 - 01.2021
Analytical Chemist
Covar Pharmaceuticals
04.2018 - 01.2019
B.Sc. - Chemistry
M.Sc. - Chemistry
Ph.D. - Chemistry
Personal Information
Title: Senior Analytical Scientist