CHAMATH CHANDRASEKERA
Hamilton,NJ
Summary
Professional scientist with strong background in quality control and analytical techniques. Passionate about integrating automation to manufacturing and QC workflows. Skilled in high-throughput laboratory testing, data analysis, and regulatory compliance. Known for effective teamwork, adaptability, and achieving precise results. Proficient in method development, validation, and problem-solving, ensuring high standards in product quality and safety.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Control Scientist
BeOne Medicines
04.2024 - Current
- Authored and executed validation protocols for qPCR, ELISA, and Cell-based potency assays for the tech transfer of TEVIMBRA
- Performed drug substance, drug product, and in-process control sample testing to support PPQ/engineering runs
- Analyzed 700+ WFI, rinse, and swab samples for TOC/conductivity for cleaning validations
- Led laboratory investigations for 10+ deviations by authoring detailed reports, conducting root cause analysis, performing complex troubleshooting, and implementing corrective actions
- Authored 10+ SOPs, validation summary reports, and discrepancies
- Executed IQ/OQ protocols for 8 analytical instruments to support the method transfer of TEVIMBRA
- Project manager for completing the Applied Biosystems AccuSeq Computer System Validation (CSV) in 6 weeks
Research Scientist II
GenScript
11.2021 - 12.2023
- Led a capital project ($10 million) to develop an automated plasmid DNA manufacturing platform with a capacity for 1000 plasmids produced per day
- Handled vendor management and negotiated optimum quotes for consumables/reagents for the DNA platform
- Performed media screens and culture optimization increasing DNA yield on the manufacturing platform by 30%
- Validated a gene synthesis method that increased DNA assembly success rate by 35%
- Produced DNA mutant libraries to perform HT gene assembly and in vitro transcription/translation of high-value products including AAV capsid variants, and sweetener peptides
- Experienced in operating liquid handlers from Tecan, Formulatrix, Thermo Scientific, Molecular Devices and SPT Labtech
Graduate Research Assistant
University of Delaware
08.2016 - 11.2021
- Projects
- 1. Identified the mechanism of ADAM9 metalloprotease in colorectal cancer progression
- 2. Expressed and purified recombinant ADAM9 protein using a baculovirus expression system
- 3. Performed a drug screen against recombinant ADAM9 using cell-based and biochemical assays
Research Technician
UNC Nutrition Research Institute
12.2015 - 06.2016
- Managed four colonies of transgenic mice including breeding, weaning, DNA extraction, and PCR genotyping
- Performed a radioenzymatic folate assay to estimate tissue folate levels of transgenic mice
- Performed cell culture and maintenance of host cell lines (HEK 293, HCT116)
- Trained in working in BSL2 and animal facilities and following biosafety and IACUC protocols
Quality Analyst
Reagents Inc
09.2015 - 11.2015
- Tested over 200 lots of chemical reagents and completed and documented quality investigations
- Manufactured over 25 batches of analytical-grade chemicals and packaged items as per customer requirements
- Responsible for ensuring accuracy and GMP compliance in documents that are being reviewed
Quality Control Technician/Sample Coordinator
Allergan
06.2014 - 05.2015
- Completed quality analytical testing and data analysis of over 1000 ophthalmic final product samples with
- Proficient in pH testing, titrations, particle sizing, and colorimetric ID tests per USP
- Identified over OOS/OOT results and performed lab investigations per 21 CFR part 211
- Performed routine/non-routine sample management operations including receipt, storage, distribution, and transfer
- Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP
Education
Ph.D. - Molecular Biology
University of Delaware
Newark, DE11.2021
B.S - Biochemistry
Baylor University
Waco, TX12.2013
Skills
- Molecular Biology: CRISPR-Cas9 gene editing, qPCR, western blotting, ELISA immunocytochemistry
- Cell Biology: Cell line generation, cell-based luciferase assay, MTT proliferation assay, potency assays
- Validation: Instrument CQV, GMP Analytical Method Validation, Validation protocols, Summary reports
- Quality Control: Analytical Testing, Deviation Investigations, Change Control, Data Review, GMP Requirements
- Project management: Microsoft Projects, Jira, Project Management Plan, Risk Register, Schedule Management
- Quality management systems
- Inspections and reviews
Certification
Project Management Professional PMI (PMP number 3768368) Expiration 30 Jan 2027
Publications
- SA Groene MD, CV Chandrasekera; T Prasad MA, AE Lincourt PhD MBA, BT Heniford MD, VA Augenstein MD. Right versus Left-Sided Colectomies: A Comparison of Outcomes. The American Surgeon 2016 Jul;82(7):580-7.
- Chandrasekera, P.†, Perfetto, M.†, Lu, C.†, Zhuo M., Bahudhanapati, H., Li, J., Chen, W.C., Kulkarni, P., Christian, L., Liu, J., Yien, Y.Y., Yu, C., and Wei, S. (2022) Metalloprotease ADAM9 cleaves ephrin-B ligands and differentially regulates Wnt and mTOR signaling downstream of Akt kinase in colorectal cancer cells. J. Biol. Chem. 298, 102225
Timeline
Quality Control Scientist
BeOne Medicines
04.2024 - Current
Research Scientist II
GenScript
11.2021 - 12.2023
Graduate Research Assistant
University of Delaware
08.2016 - 11.2021
Research Technician
UNC Nutrition Research Institute
12.2015 - 06.2016
Quality Analyst
Reagents Inc
09.2015 - 11.2015
Quality Control Technician/Sample Coordinator
Allergan
06.2014 - 05.2015
Ph.D. - Molecular Biology
University of Delaware
B.S - Biochemistry
Baylor University
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