Naveenganesh Muralidharan
Boulder,CO
Summary
Visionary biopharmaceutical leader with 20 Yrs global expertise in MSAT, Process development, process validation, and GMP manufacturing. Proven track record advancing Biologics, Gene therapy, Oligo nucleotides and Antibody Drug Conjugates (ADC) from development to launch. Known for leading high-performing teams, ensuring FDA/EMA compliance, and driving first-time-right execution. Author and contributor in International Society for Pharmaceutical Engineering (ISPE), BioProcess International, American Pharmaceutical Review, BioPharm International, and Pharmaceutical Technology.
Overview
20
20
years of professional experience
Work History
Principal Consultant
Bench2Batch LLC (CMC Lifecycle Partners)
2025.11 - Current
- Present Supporting the CMC Process Development & MSAT organization for a late-stage Oligo nucleotides and ADC programs, enabling the transition from Phase II to Phase III. Responsibilities include process characterization strategy, risk assessments, sampling plans, and authoring late-stage CMC process validation documentation supporting pivotal readiness.
- Bench2Batch.Com
- Client - Arrowhead Pharmaceuticals — CMC Process Development Consultant (Phase II → Phase III) Contract
Senior Manager MSAT (Technology Transfer & Process Validation)
AGC Biologics
2023.02 - 2025.11
- Develops and improves the efficiency of the department by setting up the department structure and updating procedures to meet the needs of the clients.
- Directs and leads activities of the department including all people management activities such as establishment of strategic plan, effective delivery of objectives and KPI, project resourcing, mentoring, training, goal setting, and performance evaluation.
- Design and lead execution of risk assessments that are compliant with company’s validation program and aligned with industry’s best practices.
- Improve alignment of Technology Transfer & PV activities globally, together with MSAT leaders at AGC’s other sites.
- Interface with the project teams to support product life cycle change management projects, including drive long-term process improvements execution.
- Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
- Lead cross-site initiatives, ensuring seamless cross-organizational interactions.
Senior Engineer, Manufacturing Science and Technology
Novartis Gene Therapy
2020.04 - 2023.02
- Leading the implementation of Continuous Process Verification (CPV) program (Stage-3 process validation), which includes policy documents and reports for Statistical Process Control (SPC) monitoring for process parameters (KPPs, CPPs and performance & quality attributes) across upstream, downstream and drug product.
- Authoring / Supporting Process Analytical Data Trend Analysis section in Annual Product Quality Review (APQR).
Senior Scientist, Upstream Viral Vector
Lonza
2019.06 - 2020.04
- Developed a robust and high-performing upstream rAAV process, which includes plasmid ratio optimization, and selection of suitable commercial growth media. Scaled up the process to 50L STR.
- Led the scale-down model successfully at 1.5L STR and verified the model’s replication of 200L.
- AAV manufacturing process using various parameter targets as qualified indicators.
- Managed successful completion of the process characterization using the Failure Mode Effects Analysis (FMEA) and the Design of Experiments (DOE) methodologies.
- Collaborated with the cross-functional teams in the development of the Target Product Profile (TPP) and the Critical Quality Attributes (CQA) for a rAAV candidate based on the FMEA analysis.
Senior /Supervisor Engineer (Tech Transfer / Process Development)
Thermo Fisher Scientific (Pharma Services Group)
2016.11 - 2019.06
- Led the tech transfer program that entailed generating tech transfer package, which includes Facility Fit Assessment, BOM, GFE, PFDs, process description/ tech transfer protocols, Master Batch Records, change controls, process-related deviation investigations, impact assessments of the deviations, CAPAs and effectiveness check on implemented CAPAs and performing QRA on the proposed and implemented process changes.
- Managed the on-the-floor support, analyzed process data, investigated & troubleshooted the manufacturing process issues, and authored the campaign summary reports.
- Served as the upstream and downstream subject matter expert for all the clinical programs.
Associate Scientist II
Medimmune AstraZeneca
2014.01 - 2016.11
- Designed and executed experiments in pilot scale bioreactors to troubleshoot the manufacturing issues.
- Performed filter sizing studies for the depth filtration step.
- Led the characterization studies for the mass transfer coefficient and the mixing time for the bench scale, pilot scale and the manufacturing scale bioreactors.
- Evaluated the operational feasibility and implemented ATF units for the perfusion process in the n-1 and manufacturing scale bioreactors.
Scientist I
Lonza Biologics
2010.12 - 2014.01
- Led the process scale up and the process transfer to manufacturing scale from the process development department and other customer sites for cell culture and primary recovery unit operations.
- Developed and prepared the technology transfer deliverables including the facility fit analysis report, BOMs, tech transfer documents, process flow diagrams and sampling plans.
- Supported the cross-functional investigation teams to investigate and resolve complex manufacturing issues via root cause analysis for the deviations and implemented effective corrective actions.
- Trained the junior scientists on new processes, implemented process changes for continuous improvement, provided on floor support during the engineering runs.
- Responsible for closely analyzing the process trends and ensured the process is under tight control.
- Presented and reported the campaign summaries to clients. Authored technology transfer documents such as process descriptions, process transfer summary report and process performance consistency report.
Scientist I – Contract
Boehringer Ingelheim Vedmedica
2010.06 - 2010.12
- Authored and executed scientific protocols for the optimization of process, media, feed , seeding density for the viral vaccine production.
- Executed media preparation, inoculum expansion in shake flask and spinners, bench scale bioreactors operations, sample analysis, data compilation and analysis.
Production Engineer
Biocon
2006.06 - 2008.07
- Gained hands on experience with media preparation & filtration process.
- Operated 10 to 1,000L stainless steel STRs which includes CIP, SIP and other cell expansion aseptic operations.
- Compiled and analyzed the run data from the GMP manufacturing.
- Contributed to the development of P&ID for the capital and expansion projects.
- Performed the qualifications and validations of fermentation process and equipment.
- Prepared process related documents such as SOPs, MFRs and MBRs.
Education
MS - Cell and Molecular Biology
University of New Haven
West Haven, CT, USA2010-12
BS - Biochemical Engineering
SASTRA University
Tanjore, TN, India2006-06
Skills
- Early-Stage process development, late-stage Process Characterization (PC)
- Tech Transfer to (Clinical & Commercial) scale
- Stage II Process Validation (PV)
- Stage III (CPV & APQR) support
- SME in SPC Data Analytics Using Python, R, JMP, MiniTab, Spotfire & SIMCA
- Strategic leader with strong technical acumen & Cross-functional leadership
- Building and motivating high-performing teams
Affiliations
- Strategic Artificial Intelligence Advisory Member | Nov 2024- Current University of Colorado, Colorado Springs, CO
- Member Editorial Advisory Board (EAB) | Dec 2024- Current Bioprocess International, New York, NY
- Contributor and Editorial Advisor | Mar 2025- Current Pharma Now, British Columbia V6Z 3C1, Canada
Timeline
Principal Consultant
Bench2Batch LLC (CMC Lifecycle Partners)
2025.11 - Current
Senior Manager MSAT (Technology Transfer & Process Validation)
AGC Biologics
2023.02 - 2025.11
Senior Engineer, Manufacturing Science and Technology
Novartis Gene Therapy
2020.04 - 2023.02
Senior Scientist, Upstream Viral Vector
Lonza
2019.06 - 2020.04
Senior /Supervisor Engineer (Tech Transfer / Process Development)
Thermo Fisher Scientific (Pharma Services Group)
2016.11 - 2019.06
Associate Scientist II
Medimmune AstraZeneca
2014.01 - 2016.11
Scientist I
Lonza Biologics
2010.12 - 2014.01
Scientist I – Contract
Boehringer Ingelheim Vedmedica
2010.06 - 2010.12
Production Engineer
Biocon
2006.06 - 2008.07
BS - Biochemical Engineering
SASTRA University
MS - Cell and Molecular Biology
University of New Haven
Publications
- Patent Application.
- Muralidharan, N. Method for Optimizing Drilled Hole Sparger Design in Large-Scale Stirred Tank Bioreactors for Enhanced Cell Culture Efficiency. U.S. Patent Application No. 19/315,755, filed September 1, 2025.
- Books Authored.
- Muralidharan, N. (2024). Biopharmaceutical Case Studies: Engineering Challenges and Practical Solutions (1st ed.). Book Writing Pioneer. ISBN: 9798324375065 https://www.agcbio.com/e-book-12-must-read-biopharmaceutical-case-studies-challenges-and-solutions-by-naveenganesh-muralidharan
- Muralidharan, N. (2025). Biopharmaceutical Process Validation: Strategies for Risk Assessment (1st ed.). Book Writing Pioneer. ISBN: 1968260293 https://www.amazon.com/Biopharmaceutical-Process-Validation-Assessments-Applications-ebook/dp/B0FK5HZ7Q2?ref_=ast_author_dp
- Peer reviewed Published Technical Articles as 1st or corresponding author.
- Muralidharan, N. (1), Phulgirkar A. Minimum Sample Size To Lock Control Limits? A Capability- and Risk-Based Approach Using PpK and Chi-Square Uncertainty. BioProcess International, 24(6), 240606. An Approach to Statistical Process Control
- Muralidharan, N. (2026, April 22). Stop Using All Eight Nelson Rules in Statistical Process Control (SPC) Charts used in Continued Process Verification (CPV) Monitoring. iSpeak, International Society for Pharmaceutical Engineering. Stop Using All Eight Nelson Rules in Statistical Process Control (SPC) Control Charts used in Continued Process Verification (CPV) Monitoring | Pharmaceutical Engineering
- Muralidharan, N. (2026, April 22). Stop Treating Nelson Rule 2 as a Checkbox in Control Charts: A Practical, Risk-Based Way to Interpret Statistical Process Control (SPC) Signals. iSpeak, International Society for Pharmaceutical Engineering. https://ispe.org/pharmaceutical-engineering/ispeak/stop-treating-nelson-rule-2-checkbox-control-charts-practical
- Muralidharan, N. (2026, April). Establishing Risk-Based Acceptance Criteria for Microbial-Control Hold-Time Samples Across the Biomanufacturing Lifecycle. American Pharmaceutical Review. https://www.americanpharmaceuticalreview.com/Featured-Articles/624925-Establishing-Risk-Based-Acceptance-Criteria-for-Microbial-Control-Hold-Time-Samples-Across-the-Biomanufacturing-Lifecycle/
- Muralidharan, N. (2026, March 19). The myth of bioreactor scale-up: A biology-first approach to achieving robust manufacturing. iSpeak, International Society for Pharmaceutical Engineering. https://ispe.org/pharmaceutical-engineering/ispeak/myth-bioreactor-scale-biology-first-approach-achieving-robust
- Muralidharan, N. (1), Kaiser A., Pelletier, P., Elkin, A. (2026, March 10). Exposing the F0 Illusion in SIP: Why Sterilization Assurance Demands More. BioProcess International, 24(3), 240304. https://www.bioprocessintl.com/qa-qc/exposing-the-f0-illusion-in-sip-why-sterilization-assurance-demands-more
- Muralidharan, N. (2026). A practical and consolidated strategy for elemental impurity-risk management in biomanufacturing. BioProcess International, 24(1), 240102. Strategy for Elemental Impurity Risk Management
- Muralidharan, N. (Dec 2025). Comprehensive Stability Assessment of Biotechnological Products: Degradation Mechanisms, Statistical Tools, and Regulatory Compliance, Part 2. Bioprocess International, 23(10), 27–31. Statistical Tools for Biologics Stability Testing
- Muralidharan, N. (Dec 2025). Rethinking Shewhart control charts for high-frequency automated data in biopharmaceutical manufacturing. American Pharmaceutical Review. https://www.americanpharmaceuticalreview.com/Featured-Articles/623246-Rethinking-Shewhart-Control-Charts-for-High-Frequency-Automated-Data-in-Biopharmaceutical-Manufacturing/
- Muralidharan, N. (Oct 2025). Comprehensive Stability Assessment of Biotechnological Products: Degradation Mechanisms, Statistical Tools, and Regulatory Compliance, Part 1. Bioprocess International, 23(10), 27–31. Statistical Tools for Biologics Stability Testing
- Muralidharan, N. Turner, A. Michor, H & Davis M (Oct 2025). From Bench to BLA Synchronizing CMC Activities with Clinical Development for Robust and Compliant Biopharmaceutical Manufacturing. Bioprocess International, 23(10), 27–31. https://www.bioprocessintl.com/process-development/scale-up-and-tech-transfer/
- Muralidharan, N. (1), Younger, T., Elkin, A., & Xian, J (May 2025). Raw Materials in Biologics Manufacturing Comprehensive Risk Assessment and Classification. Bioprocess International, 23(6), 23–29. https://www.bioprocessintl.com/biochemicals-raw-materials/raw-materials-in-biologics-manufacturing-comprehensive-risk-assessment-and-classification
- Muralidharan, N. (1), (May 2025). Understanding the Variability in Bioburden Test Results in Biomanufacturing. Pharmaceutical Technology, 20-23. https://cdn.sanity.io/files/0vw8moc6/pharmtech/b0be9d95211f540b0bb76d0b4a56c1a918ea7330.pdf/PT0525_Ezine(Watermark)_LINKED.pdf
- Muralidharan, N. (1), (Apr 2025). Investigating Bioreactor Contamination, Modeling Contaminant Introduction, and Ensuring Bioburden Test Reliability. BioPharm International, 38(3), 20-27. https://cdn.sanity.io/files/0vw8moc6/biopharn/74008d331d0638401a8d0f55b62a453c4407f674.pdf/BP0425_Ezine_watermark_Linked.pdf
- Muralidharan, N. (1), Rose, L. S., & Davis, M. (2025). Extractables and Leachable Management Comprehensive Risk Assessment During Process Validation for At-Scale Biopharmaceutical Manufacturing. Bioprocess International, 23(3)E1, 15–20. https://eu-assets.contentstack.com/v3/assets/blt0a48a1f3edca9eb0/blta4a33bc6c272c97f/67e304b79e35b10caa916477/23-3-eBook-PRI.pdf
- Muralidharan, N. (1), Rose, L. S., Younger, T., Elkin, A., Walia, M., Chan, G., & Ball, S. (2025). Microbial-Control Hold-Time Assessments: Guidance on Matrix and Bracketing Validation Approaches, 23(3), 23–34. https://www.bioprocessintl.com/validation/microbial-control-hold-time-assessments-guidance-on-matrix-and-bracketing-validation-approaches
- Muralidharan, N. (1), Rose, L. S., Younger, T., Chan, G., Ball, S., Davis, M., Bolduc, E., & Elkin, A. (2025). Buffer and solution mixing-time validation: A risk-assessment framework for analysts using matrix and bracketing approaches. Bioprocess International, 23(1-2), 23–34. https://www.bioprocessintl.com/biochemicals-raw-materials/buffer-and-solution-mixing-time-validation-a-risk-assessment-framework-for-analysts-using-matrix-and-bracketing-approaches
- Muralidharan, N. Leyla Saeedina Rose. (2024). Process Validation: Assessing the Need for At-Scale Physicochemical Stability Studies in Biologics Manufacturing. Bioprocess International, 22(11), E1. December 2024 E-Book. Retrieved from https://www.bioprocessintl.com/assays/ebook-developing-assays-considerations-across-the-analytical-spectrum
- Muralidharan, N. (1), Younger, T., Chan, G., Ball, S., Davis, M., & Bolduc, E. (2024). Maintaining protein disulfide-bond stability during culture harvest: Exploring the effects of temperature and oxygen on reduction-reaction kinetics. Bioprocess International, 22(11), E1. November 2024 E-Book. Retrieved from https://www.bioprocessintl.com/product-characterization/ebook-process-related-impurities-from-identification-to-prevention-of-product-variance
- Muralidharan, N. (1), Johnson, T., Rose, L., Davis, M. (2024, April). CPV Monitoring - Optimization of Control Chart Design by Reducing the False Alarm Rate and Nuisance Signal. Science Journal of Applied Mathematics and Statistics. https://www.sciencepublishinggroup.com/article/10.11648/j.sjams.20241202.11
- Muralidharan, N. (1), Bolduc, E., & Davis, M. (2024). Strategies Used in Manufacturing Processes to Drive and Control Mammalian Cells to Undergo a Lactate Metabolic Shift. Pharmaceutical Bioprocessing, 12(2),152-157. https://www.openaccessjournals.com/articles/strategies-used-in-manufacturing-processes-to-drive-and-control-mammalian-cells-to-undergo-a-lactate-metabolic-shift.pdf
- Muralidharan, N. (1), Tyler, Y., Chan, G., & Davis, M. (2024, March). Shear Assessment for Cell-Culture Clarification in a Disc-Stack Centrifuge. BIOPROCESS TECHNICAL, 22(3), 2-7. https://www.bioprocessintl.com/separation-purification/shear-assessment-for-cell-culture-clarification-in-a-disc-stack-centrifuge
- Muralidharan, N. (1), Bolduc, E., & Davis, M. (2024, January/February). Characterizing Oxygen Mass Transfer and Shear During Cell Culture Calculating the Maximum Cell Density Supported By a 20,000-Liter Stirred-Tank Bioreactor. Bioprocess International, 22(1-2), 2-10. https://bioprocessintl.com/2024/january-february/2024/characterizing-oxygen-mass-transfer-and-shear-during-cell-culture-calculating-the-maximum-cell-density-supported-by-a-20000-liter-stirred-tank-bioreactor/
- Muralidharan, N. (1), Lorson, D., (2024, January/February). Determining Sample Size for Demonstrating Zero Failures Ensuring the Effectiveness of Corrective and Preventive Actions. Bioprocess International, 22(1-2),1-2. https://bioprocessintl.com/analytical/qa-qc/determining-sample-size-for-demonstrating-zero-failures-ensuring-the-effectiveness-of-corrective-and-preventive-actions/
- Muralidharan, N. (1), Johnson T., Bolduc, E., Davis, M. (2024 February). CO2 Control Strategy for Large-Scale Cell Culture Bioreactor Operation. Advances in Bioscience and Bioengineering, 12(1), 1-13. https://doi.org/10.11648/abb.20241201.11
- Muralidharan, N. (1), Johnson T., & Davis, M. (2023, November 16). Identifying False Metabolite Measurements During Cell-Culture Monitoring Effective Application of the Multivariate Hotelling’s T2 Statistic. Bioprocess International, 21(11-12), 29-31. Retrieved from https://bioprocessintl.com/2023/november-december-2023/identifying-false-metabolite-measurements-during-cell-culture-monitoring-effective-application-of-the-multivariate-hotellings-t2-statistic/
- Muralidharan, N. (1), Wombaker T., Johnson T., & Bolduc, E. (2023, September 20). Validating Prefiltration Dirty-Hold Times for Upstream Media and Feed Solutions Implications for Establishing In-Process Microbial Control. Bioprocess International, 21(9), 26-35. https://bioprocessintl.com/2023/september-2023/validating-prefiltration-dirty-hold-times-for-upstream-media-and-feed-solutions-implications-for-establishing-in-process-microbial-control/
- Muralidharan, N. (2023, June 26). Specification Limits for Biomanufacturing Processes: Comparing Tolerance-Interval and Process-Capability Methods. Bioprocess International, 21(6), 40-43. https://bioprocessintl.com/analytical/qa-qc/specification-limits-for-biomanufacturing-processes-comparing-tolerance-interval-and-process-capability-methods/
- Muralidharan, N. (2023, May 17). Process Validation: Calculating the Necessary Number of Process Performance Qualification Runs. Bioprocess International, 21(5), 37-43. https://bioprocessintl.com/analytical/upstream-validation/process-validation-calculating-the-necessary-number-of-process-performance-qualification-runs/
- Muralidharan, N. (2023, April 20). Quantitative Risk Assessment of Limits for Residual Host-Cell DNA: Ensuring Patient Safety for In Vitro Gene Therapies Produced Using Human-Derived Cell Lines. Bioprocess International, 21(4), 33-37. https://bioprocessintl.com/manufacturing/cell-therapies/quantitative-risk-assessment-of-limits-for-residual-host-cell-dna-ensuring-patient-safety-for-in-vitro-gene-therapies-produced-using-human-derived-cell-lines/
- Muralidharan, N. (2023, February 9). Shear-Proof Design Space: Scaling Stirred-Tank Bioreactors for Cell Culture Processes. Bioprocess International, 21(1-2), 36-38. https://bioprocessintl.com/upstream-processing/bioreactors/shear-proof-design-space-scaling-stirred-tank-bioreactors-for-cell-culture-processes/
- Muralidharan, N. (2022, October 20). Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring. Bioprocess International, 20(10), 20-24. https://bioprocessintl.com/manufacturing/process-monitoring-and-controls/statistical-method-for-establishing-control-limits-for-nonnormal-data-distribution-focus-on-continued-process-verification-monitoring/
- Conference Proceedings.
- Muralidharan N. (2018, November), Small Scale Bioreactor Model Development that Mimics the Manufacturing Scale CO2 Profile. paper presented at the water side conference development and production of therapeutic proteins. https://www.academia.edu/165324676/Small_Scale_Bioreactor_Model_Development_that_Mimics_the_Manufacturing_Scale_CO2_Profile