MALAY M. CHAN
Omeros Corporation
24
Years of experience
Demonstrates expertise in analytical development and method qualification for monoclonal antibodies, with a focus on regulatory submissions and commercial approval. Proven contributions to the approval of biologic products and support for manufacturing readiness through leading analytical investigations and mentoring. Knowledgeable in cGMP, ICH-GCP, and regulatory requirements.
Work History
Principal Research Associate, Analytical Science
3 Years 5 Months- Led development, qualification, and transfer of cIEF and cE-SDS methods supporting monoclonal antibody and fusion protein characterization, PPQ activities, and CMO manufacturing readiness.
- Designed, executed, and optimized analytical methods (cIEF and cE-SDS) for formulation screening and mini-qualification, while supporting routine testing (SEC, cIEF, ProtA titer, CEX, R-HPLC) and maintaining laboratory operations.
- Analytical support for product characterization (PC), and processes performance qualification (PPQ) of the mAb upstream and downstream manufacturing processes. Design of lot-to-lot comparability and identification critical quality attributes (CQA) study.
- Charge profile fractionation using MauriceFlex system, icIEF-MS (Peptide mapping, Intact mass) for mAb characterization. Routine stability testing using multiple assays to understand long-term stability and monitor degradation for multiple lots of a mAb product (cIEF, cE-SDS, SEC, RP).
- Conducted stability testing on new formulations to ensure product quality.
- Trained and supervised new employees on assay preparation data evaluation and reporting.
- Authored multiple technical reports and worked cross-functionally to present data to drive program direction and decision making.
- Managed reagent inventory and organized laboratory supplies, facilitating smooth laboratory operations.
Senior Analytical Development Associate
8 Years 5 Months- Optimized and qualified methods (cIEF and cE-SDS) for PACAP to enhance assay performance.
- BLA filing for ALD403 (Eptinezumab?jjmr)
- Lab to Lab assay testing (Lunbeck, Fujifilm, Althea, Sandoz, Lonza)
- Master Clone Poll screening (PACAP)
- Performed charge variant offgel fractionation to separate protein variants.
- Performed degradation study to assess stability
- Method transfer and validation
- Routine/non-routine testing (stability and new formulation)
- Collaborated with QC and QA teams for quality assurance
- CMO visit for assay troubleshooting
- Managed inventory of reagents and organized laboratory space to ensure operational efficiency.
- Supported Vyepit approval team by collaborating on project tasks and documentation.
Analytical Development Associate
2 Years- Routine/non-routine testing (Stability samples, R & D samples, Pre-clinical samples)
- Executed the method transfer process to a contract manufacturing organization (CMO), ensuring compliance with regulatory standards.
- Presented data to pharmaceutical operations group, facilitating informed decision-making.
- Supported research and process development by evaluating and characterizing proteins using SDS-PAGE and UV A280 methods, contributing to better understanding of protein behavior. Carbohydrate analysis through Aminex and SEC using ChemStation. Conduct stability studies on preclinical materials. Optimize Potency ELISA for ALD403. Addendum to cE-SDS assay qualification, generate and author a qualification report. Create new Operation and Maintenance procedures for cE-SDS assay. Revise test protocol for cIEF assay for TP029. Support assay transfer to CMO.
Senior Quality Control Associate
2 Years 2 Months- Support Corporate Clinical Manufacturing and Clinical Stability Team by performing in-process, final product, and stability testing of Dendreon products using the following techniques: 2 color flow cytometry (Beckman FC500) using MXP Software, sandwich based ELISA, LAL endotoxin, gram stain, complete blood count using Beckman Coulter Act 5 diff CP Hematology Analyzer.
- Qualified new control for Act 5diff CP Hematology Analyzer and calibrated Act 5diff CP Hematology Analyzer. Perform release and stability testing on protein products using RP-HPLC and SEC-HPLC, UV-A280, pH, Appearance, and SDS-PAGE.
- Reviewed assays and facilitated method transfer and validation between QC clinical sites in Seattle, New Jersey, and Seal Beach for Whole Cell Imaging Cytometry using Cellometer Vision to enhance consistency and reliability.
- Performed manual leukocyte differentiation using established protocols. and viability using Trypan Blue Exclusion method, Automated Whole Cell Imaging Cytometry using Cellometer Vision, Sterility sampling testing using BacT/Alert System and Environmental Monitoring for in-process and final product.
- Collaborated with Quality Assurance and Manufacturing departments to align processes and ensure product integrity.
- Executed monthly and semi-annual maintenance on Beckman Coulter Act 5 diff CP Hematology Analyzer, ELx808 Ultra Microplate readers, Beckman Coulter FC500, HT Biotek Multi-Mode Microplate Reader, microcentrifuge, and HT incubator/shaker to ensure optimal performance and compliance.
- Receive and maintain test samples, reagents and reference standards used in the laboratory ensuring a well documented and approved process is followed.
- Spent 3 weeks at New Jersey QC commercial site for Flow cytometry and ELISA training.
Research Associate II
2 Years 1 Month- Develops, optimizes, implements, and quality of new analytical protocols and test methods for new drug products. Implementation of routine maintenance and troubleshooting analytical instruments.
- Supported upstream/downstream the upstream/downstream process development and formulation team by evaluating and characterizing proteins using techniques such as SEC HPLC, gel electrophoresis, densitometry, and ELISA, ensuring high-quality analytical results.
- Supported lot release testing and monitored a stability program for product, reference standard, and in-process stability; assessed and established sample acceptance criteria, and issued Certification of Testing for Lot Release to maintain compliance.
- Monitored retest and stability dates to ensure project timeline compliance; communicated with internal and external project teams and conducted peer laboratory notebook and documentation reviews.
- Conduct stability studies on preclinical materials.
- Characterize key raw materials and reference standards.
Quality Control III
5 Years 6 Months- Coordinated with three analysts to qualify critical reagents, ensuring compliance and accuracy for Protein A calibration standard, CHOP 2nd Ab qualification, and HRP-Conjugate.
- Design and perform validation of new lab instruments (BioRad scanner densitometer and Beckman Coulter Capillary Electrophoresis PA 800) and experiments for new and existing analytical methods. Coordinating and scheduling a vendor to troubleshoot lab instruments and lab equipment.
- Review and evaluate method transfer/method validation from Analytical lab to QC lab.
- Support lot release testing, product stability, reference standard stability, and in-process testing through analytical methods using gel SDS-PAGE, vertical IEF, Dot Blot, CHOP and residual Protein A ELISA.
- Created and edited SOPs and test methods, enhancing laboratory compliance and operational efficiency.
- Perform analytical methods such as ELISA (Protein A and CHOP) and immunofluorescent-based assays (BioVeris Immunoassay), Capillary Electrophoresis using either Beckman Coulter with 32 Karat software or Agilent Technologies with ChemStation software (rCE- SDS and cIEF), SDS-PAGE gel electrophoresis (Silver and Coomassie stain, IEF, and IEF-Western), Osmolarity, Clarity, pH, appearance determination, UV spectrophotometry, Densitometry, and Dot Blot.
- Coordinating and scheduling weekly testing of in-process samples and standards preparation for a group of six analysts. Conduct laboratory investigations (NC/CAPA), technical transfer, and lab to lab assaying comparison.
- Generated assay investigation result reports and authored qualification summary reports, while developing testing protocols for new methods; contributed to the Capillary Electrophoresis training video module and supported commercial product testing at Amgen Colorado for three months.
- Equipment IQ/OQ/PQ, and calibrate analytical instruments and lab equipments.
Quality Control Associate
4 Months- Conducted testing of de-ionized water systems, raw materials, bulk and final products, and stability components to ensure compliance with QC goals. Assessing protein purity by SDS-PAGE and IEF analysis, LAL Endotoxin, cell cultivation and counting, tissue culture, material analysis utilizing IR instrumentation, pH analysis, acid-base titration, UV/vis, ELISA Immunoreactivity and HPLC. Monitored controlled environments utilized by the Manufacturing Department. Compiled data for documentation of test procedures and prepared reports on test results, adhering to cGMP, SOP, STM, USP, and ACS standards.
- Inspected raw materials and finished products for quality compliance.
- Conducted routine audits to maintain regulatory standards.
- Documented inspection results and maintained accurate records.
Education
Bachelor Degree - Biochemistry
Skills
Analytical Techniques: cIEF
cE-SDS
SEC-HPLC
RP-HPLC
CEX
Protein A Titer
ELISA
SDS-PAGE
Flow Cytometry
Glycan Analysis
Mass Spectrometry
cell viability
Western Blotting
SDS-PAGE
Method development & validation
Regulatory & Quality: cGMP
GLP
CFR Part 11
Method transfer
PPQ
BLA Support
Stability programs
CMO Management
ICH Guidelines
LIMS
ELN
Software: SoftMaxPro
Chromeleon
32Karat
ChemStation
ChromPerfect
LIMS
Empower
Compass for iCE
Veeva
Analytical techniques
Timeline
Principal Research Associate, Analytical Science
Omeros Corporation
01.2023 - 06.2026Read More
Senior Analytical Development Associate
Lundbeck Seattle (formerly AlderBio)
07.2014 - 12.2022Read More
Analytical Development Associate
AlderBio
07.2012 - 07.2014Read More
Senior Quality Control Associate
Dendreon
04.2010 - 06.2012Read More
Research Associate II
Trubion Pharmaceutical
03.2008 - 04.2010Read More
Quality Control III
Amgen Inc.
09.2002 - 03.2008Read More
Quality Control Associate
NeoRx Corporation
04.2002 - 08.2002Read More
University of Washington
Bachelor Degree from Biochemistry
Read More