Personal information

Upstream MSAT Tech Transfer Process validation PPQ CPV process development
United States

Biography

EXPERIENCE SUMMARY

I offer 16+ years of progressive leadership in parenteral biologics and gene therapy platforms (process development, scale up, technology transfer to commercial scale manufacturing).
ABOUT Me
I am a highly motivated and focused leader in the biopharmaceutical MSAT (Clinical & commercial) and late stage Process Development (PD) with through understanding of MSAT and PD support for biological product’s life cycle management. I have a detail technical understanding of processes and can also lead teams, focusing to deliver projects right at first time and on time. Skilled in building motivated teams and make strategic change for improvement.
AREA OF EXPERTISE
• Leading process development, scale up, tech transfer and Manufacturing support functions with strong record of trouble shooting productivity and product quality issues at manufacturing scale.
• Excelled in leading process characterization Studies using Quality by design tools like FMEA and DOE as recommended by ICH Q8(R2)
• Experienced with both suspension (NSO, CHO) and adherent (HEK293) cell lines.
• Excelled in managing Stage 3 Process validation - Continues Process Verification (CPV) program.

Activities

Employment (7)

AGC Biologics: BOULDER, Colorado, US

2023-02-04 to present | Sr Manager (MSAT)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Novartis Gene Therapy: Libertyville, ILLINOIS, US

2020-04 to 2023-02 | Sr Engineer (MSAT)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Thermo Fisher Scientific: St Louis, Missouri, US

2016-11 to 2019-06 | Sr Engineer (MSAT)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Astrazeneca: Gaithersburg, Maryland, US

2014-01 to 2016-11 | Associate Scientist II (MSAT)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Lonza Biologics: Portsmouth, NH, US

2010-12 to 2014-01 | Associate II and Scientist I (MSAT)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Boehringer Ingelheim: Fort Dodge, Iowa, US

2010-06 to 2010-12 | Scientist I (Bioprocess Development)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Biocon (India): Bengaluru, Karnataka, IN

2006-06 to 2008-08 | Manufacturing Engineer (Manufacturing)
Employment
Source: Self-asserted source
Naveenganesh Muralidharan

Education and qualifications (1)

University of New Haven: West Haven, Connecticut , US

2008 to 2010 | Cell and Molecular Biology (Cell and Molecular Biology)
Education
Source: Self-asserted source
Naveenganesh Muralidharan

Works (10)

CO<sub>2</sub> Control Strategy for Large-Scale Cell Culture Bioreactor Operation

Advances in Bioscience and Bioengineering
2024 | Journal article
Contributors: Naveenganesh Muralidharan; Thatsinee Johnson; Emma Bolduc; Mark Davis
Source: check_circle
Web of Science Researcher Profile Sync

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
2024-02-01 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Validating Prefiltration Dirty-Hold Times for Upstream Media and Feed Solutions Implications for Establishing In-Process Microbial Control

Bioprocess International
2023-11-19 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Identifying False Metabolite Measurements During Cell-Culture Monitoring Effective Application of the Multivariate Hotelling's T 2 Statistic

Bioprocess International
2023-11-16 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Specification Limits for Biomanufacturing Processes: Comparing Tolerance-Interval and Process-Capability Methods

Bioprocess International
2023-06-26 | Magazine article | Writing - review & editing
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Process Validation Calculating the Necessary Number of Process Performance Qualification Runs

Bioprocess International
2023-05-17 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

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
2023-04-20 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Shear-Proof Design Space: Scaling Stirred-Tank Bioreactors for Cell Culture Processes

2023-02-09 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring

Bioprocess International
2022-10-20 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan

Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring

Bioprocess International
2022-10-20 | Magazine article
Contributors: Naveenganesh Muralidharan
Source: Self-asserted source
Naveenganesh Muralidharan