Scientist with 6+ years of experience supporting pharmaceutical, analytical testing, and cell therapy operations in GMP-regulated laboratory operations. Experienced in analytical method execution, mammalian cell handling, laboratory investigations, SOP development, technical documentation. Proven ability to independently execute studies, manage projects, support cross functional teams while maintaining compliance with GMP and GLP requirements.
Work History
Scientist
1 Year 3 Months
West Pharmaceutical Services | 04.2025 - Current
Independently manage projects from initiation through completion, including planning, execution, documentation, and reporting.
Conduct laboratory investigations, including Out-of-Specification (OOS) ensuring thorough root cause analysis and corrective actions, and deviation reports.
Conducted laboratory investigations, including Out-of-Specification (OOS) assessments, ensuring thorough root cause analysis, corrective actions, and compliance with deviation reporting.
Authored and revised work instructions, SOPs, and technical documentation to enhance clarity and consistency in laboratory processes.
Train laboratory personnel on established techniques and mentor junior staff.
Collaborated with cross-functional teams to ensure alignment and support for customer projects, contributing to successful project outcomes.
Associate Scientist III
3 Years 2 Months
West Pharmaceutical Services | 02.2022 - 04.2025
Conducted analytical testing for internal and external clients, ensuring compliance with GMP standards.
Documented results in real time within LIMS and communicated critical findings to cross-functional teams.
Supported laboratory investigations such as LIRs, Deviations, OOS, study protocols.
Assisted with revisions of SOPs and contributed to continuous process improvements to enhance operational efficiency.
Maintained compliance with GMP, GLD, and data integrity requirements.
Aseptic Manufacturing Technician II
1 Year 4 Months
Iovance Biotherapeutics | 07.2021 - 11.2022
Executed end-to-end GMP manufacturing support for clinical and commercial autologous cell therapy products in ISO Class 5 cleanroom environments.
Led suite preparation, material transfers, tumor receipt, and Chain of Identity and Chain of Custody documentation to ensure regulatory compliance and product traceability.
Reviewed and revised batch records and logbooks, ensuring compliance and timely escalation of deviations and operational risks to management.
Trained team members in aseptic operations, including media prep, thaw, passage, harvest, and gowning qualification, enhancing operational readiness.
Aseptic Manufacturing Technician I
9 Months
Iovance Biotherapeutics | 10.2020 - 07.2021
Performed clinical operations and manipulations in grade B environment, ensuring compliance with GMP regulations.
Operated, cleaned, and maintained manufacturing equipment in accordance with GMP requirements.
Handled disposal of hazardous materials in accordance with GMP requirements and safety procedures.
Documented activities in batch-related documentation and equipment logbooks per good documentation practices.
Conducted laboratory experiments independently under minimal supervision.
Cell Manufacturing Technician
7 Months
Wuxi AppTec | 10.2019 - 05.2020
Supported GMP manufacturing cell and gene therapy products for clinical and commercial programs.
Operated cell processing equipment, ensuring precise execution of final product fill activities.
Documented batch production records to ensure accuracy and compliance and SOPs revisions to improve process accuracy and documentation compliance.
Collaborated with team members to streamline workflows, enhancing overall operational efficiency.
Quality Control Technician
5 Months
Ready Pac | 10.2018 - 03.2019
Conducted chemical and physical testing of raw and finished products to verify quality and compliance standards.
Performed GMP inspections and audits to ensure adherence to food safety programs and minimize risks.
Utilized pH meters, oxygen meters, and titration methods for analysis to support quality assurance processes.