Arunkumar Arumugam
Collegeville,USA
Summary
Drug product and process development scientist leading end-to-end CAR-T and viral vector programs, including formulation, aseptic processing, fill-finish, cryopreservation, and technology transfer. Apply QbD, DOE, FMEA, stability studies, and comparability studies to define process understanding. Close CMC readiness gaps to support GMP clinical manufacturing and regulatory submissions. Led technology transfer of three cell therapy processes, supported pre-IND/IND packages and FDA responses, and advanced CAR-T, AAV, adenoviral, and lentiviral programs through robust process characterization and risk-based control strategies.
Overview
20
20
years of professional experience
Work History
Associate Principal Scientist Drug Product
SK PHARMTECO/ CENTER FOR BREAKTHROUGH MEDICINES
King of Prussia, PA
06.2022 - 09.2026
- Lead formulation and drug product process development for AAV, adenoviral and lentiviral vector therapeutics, including formulation optimization, aseptic processing, sterile filtration, fill-finish, primary container-closure selection, stability characterization and process scale-up for GMP clinical production.
- Develop scalable drug product manufacturing processes from laboratory development through pilot manufacturing with consideration of GMP and commercial manufacturing requirements.
- Led end-to-end cell therapy process development and optimization for autologous and allogeneic CAR-T programs, including T-cell isolation, activation, transduction, expansion, cryopreservation, drug product formulation, and fill-finish, ensuring GMP readiness for clinical manufacturing.
- Led optimization of LN2-dependent and LN2-free controlled-rate cryopreservation processes, enhancing product quality and ensuring batch-to-batch consistency.
- Design and execute process characterization, formulation robustness, filter retention, hold-up volume, accelerated/intermediate/long-term stability, forced degradation, and comparability studies to enhance product and process understanding supporting regulatory submissions.
- Apply Quality by Design (QbD), Design of Experiments (DoE), FMEA and risk-based approaches to define CQAs/CPPs, establish formulation design space, identify product/process risks and develop data-driven mitigation strategies.
- Lead laboratory-to-GMP technology transfer activities, including process characterization, process risk assessments, batch record review, pilot manufacturing support, manufacturing training and preparation of technology-transfer documentation.
- Support pre-IND and IND activities, including review of regulatory filings, design of development studies to address FDA queries, and generation of forced-degradation, comparability and stability data supporting regulatory submissions.
- Support FDA query responses and develop follow-up studies addressing regulatory expectations for drug product stability, manufacturing and process development.
- Lead manufacturing investigations and root-cause analyses using Fishbone and FMEA to resolve formulation, container-closure and fill-finish process deviations and improve process robustness.
- Evaluate primary container-closure systems, including glass and polymer vials, to characterize adsorption, formulation/container compatibility and impacts on injectable biologic stability and potency; design and execute filter-sizing studies for pilot-scale manufacturing.
- Characterize drug product quality attributes using orthogonal analytical approaches, including DLS, ddPCR, CE-SDS, SEC, AUC, subvisible particle analysis, potency assays and capsid integrity assessments, to support formulation and process-development decisions.
- Author and review process development reports, pilot-run summaries, SOPs, process-development and optimization protocols, process-flow diagrams and technology-transfer packages supporting transition from development to GMP manufacturing.
- Provide technical leadership and mentorship to scientists and cross-functional project teams supporting advanced-therapy development and manufacturing readiness.
Senior Scientist Process Development
WUXI ADVANCED THERAPIES
Philadelphia, PA
11.2020 - 06.2022
- Served as team lead for CAR-T cell therapy process development, establishing end-to-end process development and optimization strategies to improve technical completeness, GMP readiness and commercial manufacturing readiness.
- Developed and technology-transferred three cell therapy manufacturing processes for clinical use, generating key development data that supported IND filing.
- Designed and executed process-development studies to optimize autologous CAR-T manufacturing unit operations and define critical process parameter targets and operating ranges.
- Led technology-transfer activities for cell therapy drug product manufacturing, collaborating with Analytical Development, Supply Chain, Manufacturing, Quality Assurance, Facilities, and client project teams to achieve program objectives and ensure manufacturing readiness.
- Optimized first- and second-generation autologous CAR-T platforms, enhancing cryopreservation processes with both LN2-dependent and LN2-free controlled-rate freezing technologies.
- Developed and delivered allogeneic CAR-T manufacturing processes for multiple myeloma and non-Hodgkin lymphoma programs.
Scientist Process Development
WUXI ADVANCED THERAPIES
Philadelphia, PA
11.2020 - 06.2022
- Optimized viral-vector (AAV and lentiviral) and non-viral gene-transfer approaches, including electroporation using MaxCyte and 4D Nucleofector platforms, for primary T cells, PBMCs and NK cells.
- Authored process development and technology-transfer packages, training scientists and manufacturing associates on client-specific processes, GMP compliance, and process documentation requirements to ensure adherence to industry standards.
- Led cross-functional teams to advance cell therapy programs into GMP manufacturing, coordinating technical activities and facilitating execution of client programs to meet regulatory standards.
- Mentored junior scientists and trained new employees in formulation development, GMP compliance, and technical documentation best practices, fostering a culture of quality and compliance.
- Partnered with Business Development and Project Management to define technical project scope, prepare Statements of Work and align development activities with client requirements.
Scientist
AI BIOSCIENCES
College Station, TX
11.2017 - 10.2020
- Acquired 248k NIH grant for the company to develop a rapid assay for COVID detection.
- Led biomarker discovery and target validation efforts for oropharyngeal cancer and infectious disease diagnosis.
- Developed and validated multiplex nucleic acid assays for flu and COVID.
- Served as key personnel on projects, delivering products to NASA and NIH while training scientists in assay techniques and device handling.
- Authored SOPs, reviewed SOPs, and validated diagnostic assays.
- Collaborated with JPL, UCSF, and University of Vermont scientists to develop and validate sample preparation devices and protocols.
Research Scientist
TEXAS A&M UNIVERSITY
College Station, TX
08.2016 - 11.2017
- Identified intracellular fate of the long-lasting rFVIIIc and rFIXFc to inform therapeutic strategies.
- Established in vitro epithelial cell model to investigate endosomal drug and protein uptake mechanisms.
- Worked with antibody and Fc-fusion therapeutics to investigate intracellular trafficking, recycling mechanisms, and cellular uptake
- Conducted development and testing of antibody-drug conjugates.
Postdoctoral Research Associate
TEXAS TECH UNIVERSITY
El Paso, TX
11.2009 - 08.2016
- Analyzed signaling pathways including cell cycle, apoptosis, hormone, and growth factor receptor pathways using flow cytometry, immunofluorescence, Western blotting, ELISA, immunoprecipitation, cell-based bioassays, and PCR-based microarrays in primary 2D and 3D cell cultures to support research objectives.
- Established stable knock-out and overexpression cell lines through transduction (lentiviral system) and transfection (lipofection and electroporation) to validate therapeutic targets, enhancing functional assay reliability.
- Conducted interdisciplinary research at Texas Tech University laboratory facilities.
- Designed experiments aligned with Texas Tech University research objectives.
- Analyzed data using statistical software and university research systems.
Postdoctoral fellow
UNIVERSITY OF MANITOBA
Winnipeg, Canada
01.2007 - 08.2009
- Identified target genes of estrogen receptor beta as potential therapeutic targets, contributing to the advancement of cancer treatment strategies.
- Reviewed scientific articles for publications like Molecular and Cellular Biochemistry and Journal of Cell Death, enhancing scientific discourse and knowledge dissemination in the field.
- Conducted advanced research within the University of Manitoba academic laboratories.
- Analyzed experimental data using statistical software and research methods.
Education
Ph.D. - Biochemistry
University of Madras
India01-2006
M.S. - Biochemistry
Bharathiyar University
India01-2001
B.S. - Biochemistry
University of Madras
India01-1999
Skills
- Process Development
- Formulation Development
- Aseptic Filling
- Process Optimization
- CAR-T Formulation
- RPE/RPC Formulation
- Cryopreservation
- Drug Product Development
- Freeze-Thaw
- Aseptic Processing
- Fill-Finish
- Forced Degradation
- Stability Studies
- Comparability Studies
- Process Scale-up
- Technology Transfer
- GMP Manufacturing
- Sterile Filtration
- Process Robustness
- Cell-based Potency Assay
- Confocal microscopy
- Live Cell Imaging
- ELISA
- DLS
- dPCR
- Immunofluorescence
- Subvisible particle analysis
- Headspace Analysis
- Capsid Integrity
- PF-7 Filler
- FP-50 Filler
- Crystal M1 Filler
- Big-Tuna
- Stunner
- Uncle
- Light House-CCIT
- Hitachi (UC)
- WAVE Bioreactor
- LOVO
- CliniMACS Plus
- Prodigy
- Sepax Pro
- Flow cytometry
- QbD
- DoE
- JMP
- MODDE
- FMEA
- Fishbone
- ICH
- CFR
PUBLICATIONS
- 46 peer-reviewed publications
- H-index: 29
- I10-index: 44
- Scientific reviewer for multiple peer-reviewed journals
- Pubmed My Bibliography-https://www.ncbi.nlm.nih.gov/myncbi/14CVzFE2jq5k6/bibliography/public/
- Google scholar citations- https://scholar.google.com/citations?hl=en&user=JeYc2GMAAAAJ&view_op=list_works&sortby=pubdate
Timeline
Associate Principal Scientist Drug Product
SK PHARMTECO/ CENTER FOR BREAKTHROUGH MEDICINES
06.2022 - 09.2026
Senior Scientist Process Development
WUXI ADVANCED THERAPIES
11.2020 - 06.2022
Scientist Process Development
WUXI ADVANCED THERAPIES
11.2020 - 06.2022
Scientist
AI BIOSCIENCES
11.2017 - 10.2020
Research Scientist
TEXAS A&M UNIVERSITY
08.2016 - 11.2017
Postdoctoral Research Associate
TEXAS TECH UNIVERSITY
11.2009 - 08.2016
Postdoctoral fellow
UNIVERSITY OF MANITOBA
01.2007 - 08.2009
Ph.D. - Biochemistry
University of Madras
M.S. - Biochemistry
Bharathiyar University
B.S. - Biochemistry
University of Madras