Hi, I’m
YOGESH K. KHANOLKAR
Head Central Quality Control (CQC)
Mumbai
Summary
Senior Quality Control leader with over 20 years of experience in Biosimilars, Biologics, Monoclonal Antibodies, Cytokines, Hormones, Small Molecules, and Chemical Formulations. Currently heading Central Quality Control at Reliance Life Sciences. Highly experienced in USFDA, EMA, MHRA, WHO, and CDSCO regulatory inspections, data integrity, analytical governance, and building inspection-ready QC organizations.
Overview
18
years of professional experience
Work History
Dhirubhai Ambani Reliance Life Sciences
Head – Central Quality Control (CQC) Biosimilar
09.2023 - Current
Job overview
- Lead Central QC operations for Biosimilars, Biologics, and Pharmaceuticals.
- Own QC compliance for USFDA, EMA, MHRA, WHO, and CDSCO inspections.
- Drive ALCOA+ data integrity culture and electronic data governance.
- Review and approve analytical data, chromatograms, COAs, and stability trends.
- Govern analytical method lifecycle including validation, verification, and transfer.
- Lead stability programs for Drug Substance and Drug Product.
- Manage reference and working standard lifecycle.
- Lead investigation systems including OOS, deviations, CAPA, and change control.
- Mentor senior QC leaders and strengthen inspection readiness culture.
USV Biotechnology Research Lab (Quality)
AGM– Analytical Biotechnology QC Head
02.2014 - 08.2023
Job overview
- Headed analytical QC for biologics and biosimilars.
- Managed raw material, in-process, finished product, and stability testing.
- Reviewed and approved analytical method validation and transfers.
- Governed reference standard and stability lifecycle programs.
- Successfully supported multiple USFDA, MHRA, WHO, and State FDA inspections.
USV Research & Development Center
Assistant Manager – Analytical R&D
11.2009 - 02.2014
Job overview
- Analytical method development and validation for biotechnology products.
- Supported method transfers and regulatory readiness.
Famy-Care / Accutest Research Center
Senior Research Officer / Research Associate
09.2007 - 11.2009
Education
Vinayaka Mission Salem University
M.Sc. from Biotechnology
Mumbai University
B.Sc. from Biotechnology
Somaiya Mamangmwent Mumnbai
MBA from Strategy
06.2026
Skills
HPLC, GC, HPTLC, UV, FTIR, Karl Fischer, TOC
CORE COMPETENCIES
- USFDA & Global Regulatory Audit Management
- ALCOA+ Data Integrity & Electronic Compliance
- QC Operations – Biologics & Biosimilars
- Analytical Method Validation, Transfer & Lifecycle
- Stability Program Governance
- OOS, OOT, Deviations, CAPA, Change Control
- Reference & Working Standard Management
- Risk Assessment & QMS Effectiveness
- LIMS Governance & Audit Trail Review
- Team Leadership & Talent Development
Timeline
Head – Central Quality Control (CQC) Biosimilar
Dhirubhai Ambani Reliance Life Sciences
09.2023 - Current
AGM– Analytical Biotechnology QC Head
USV Biotechnology Research Lab (Quality)
02.2014 - 08.2023
Assistant Manager – Analytical R&D
USV Research & Development Center
11.2009 - 02.2014
Senior Research Officer / Research Associate
Famy-Care / Accutest Research Center
09.2007 - 11.2009
Vinayaka Mission Salem University
M.Sc. from Biotechnology
Mumbai University
B.Sc. from Biotechnology
Somaiya Mamangmwent
MBA from Strategy