Ruchi Bansal
Littleton,MA
Summary
Highly accomplished Quality Control leader with 16 years of progressive experience in biologics and cell & gene therapy (CGT) across QC operations, analytical development, method validation, and regulatory support. Proven success managing method transfer, product release, stability programs, environmental monitoring, investigations, and cGMP regulatory compliance for clinical and commercial facilities. Expert in collaborating with cross-functional teams and CMOs/CTOs, establishing scalable QC systems, and driving innovative analytical solutions that ensure safe, compliant, and on-time drug product release.
Overview
16
16
years of professional experience
Work History
QC Manager
Lonza Houston Inc.
Littleton, USA
10.2022 - Current
- Lead QC operations covering raw materials, in-process samples, product release, stability testing, and equipment qualification for the CGT manufacturing site.
- Manage method transfer, feasibility, qualification, and validation for both compendial and advanced assays supporting Cell and Gene Therapy products.
- Author, review, and approve critical quality documents including protocols, validation reports, Lot Release Protocols (LRP), Certificates of Testing (CoT), test methods, deviations, OOS/OOT investigations, and change controls.
- Design and manage cGMP stability programs for Drug Substance (DS) & Drug Product (DP), including strategies for accelerated and long-term storage, trending, and shelf-life determination for EV-based CGT products.
- Led environmental and utility monitoring programs, including EMPQ, HACCP, and risk-based microbial controls for clinical and pilot facilities.
- Serve as the primary technical liaison for multiple CMOs/CTOs, ensuring alignment with internal quality expectations, analytical performance, and project timelines.
- Implemented standardized documentation systems and laboratory quality improvements, driving high operational efficiency and regulatory compliance.
- Impact Highlight: Established the end-to-end stability and trending framework for a novel EV-based product.
- Impact Highlight: Enabled successful assay transfer and qualification across multiple vendor sites, accelerating clinical readiness.
- Cell & Gene Therapy Unit
Lead, Analytical Development
Dr. Reddy’s Laboratories
, India
12.2009 - 06.2022
- Led a team of 12 analytical scientists supporting Chemistry, Manufacturing, and Controls (CMC) activities for multiple mammalian biologics from discovery through commercialization.
- Designed and executed comprehensive ICH-compliant stability programs; trended data to establish shelf life, degradation pathways, and product specifications.
- Developed and qualified a wide range of analytical methods including HPLC/UPLC, CE-SDS, cIEF, SEC-MALS, mass spectrometry, and ligand-binding assays for monoclonal antibodies, fusion proteins, and growth factors.
- Prepared CMC technical reports and authored analytical sections for global regulatory submissions (IND, IMPD, BLA), successfully responding to regulatory queries.
- Drove successful method transfer to QC and collaborated extensively with Regulatory Affairs, Quality Assurance, Manufacturing, and Process Development teams.
- Achievement: Filed a provisional patent for a novel mixed-mode chromatography separation strategy.
- Achievement: Delivered complete analytical packages for multiple global regulatory filings, enabling advancement into late-stage clinical trials.
Education
Executive Program in Operational Management -
Indian Institute of Management – Kozhikode (IIM-K)
India05.2022
Junior Research Fellow (JRF) -
National Brain Research Center
Gurgaon, India12.2009
B.Tech. - Biotechnology
Ambala College of Engineering, Kurukshetra University
India06.2008
Skills
- Quality Control & cGMP Leadership: 16 years of expertise in leading QC Operations for Biologics and Cell & Gene Therapy (CGT), ensuring compliance with cGMP
- Method Life Cycle Management: Specialist in Method Transfer, Qualification, and Validation, supporting release and Stability Programs
- Compliance & Investigations: Proficient in managing OOS/OOT Investigations, CAPA, Change Control, and providing Audit Support
- Advanced Analytical Skills: Hands-on expertise with HPLC/UPLC, SEC-MALS, CE-SDS, cIEF, Mass Spectrometry (Q-ToF, MALDI), and molecular assays (ELISA, qPCR)
- Quality Systems: Experienced in Environmental Monitoring, Utility Monitoring, Documentation, SOPs, and statistical analysis (JMP)
- Team Leadership: Strong abilities in Cross-Functional Team Leadership and Vendor Management for process improvement
Selected Achievements
- Awarded Stellar Best Performance (4x) in categories including Innovative Analytical Approach and Team Collaboration.
- Provisional Patent filed for novel mixed-mode chromatography method for highly sialylated glycoforms.
- Qualified GATE 2008 (Graduate Aptitude Test in Engineering).
References
Available Upon Request
Timeline
QC Manager
Lonza Houston Inc.
10.2022 - Current
Lead, Analytical Development
Dr. Reddy’s Laboratories
12.2009 - 06.2022
Executive Program in Operational Management -
Indian Institute of Management – Kozhikode (IIM-K)
Junior Research Fellow (JRF) -
National Brain Research Center
B.Tech. - Biotechnology
Ambala College of Engineering, Kurukshetra University