GOVINDARAJAN SRINIVASAN
Navi Mumbai
Summary
Senior analytical and regulatory leader with 18+ years of experience in pharmaceutical, medical device, and bioanalytical fields. Proven expertise in Extractables & Leachables (E&L), nitrosamines, impurity profiling, and HRAM/LC-MS/MS/GC-MS techniques. Demonstrated success in building and leading large analytical teams, designing USP-compliant E&L strategies, supporting global regulatory submissions, and addressing USFDA queries. Professional managerial candidate with deep understanding of operational excellence and team leadership. Proven ability to drive growth and enhance productivity through strategic planning and effective resource management. Emphasizes collaboration and adaptability to meet organizational goals, showcasing excellent problem-solving and decision-making abilities.
Overview
19
19
years of professional experience
1
1
Certification
Work History
General Manager
ALS (Formerly Analytical Solution)
05.2025 - Current
- Leading 30 members team of E&L for small molecules (Parenteral/Injectable, Topical (Ophthalmic and Derma), and Inhalers) and Biological (mAB) drug products, Manufacture processing components, Small and Large Parenteral volume bag.
- Design E&L protocols per USP 665, 1660, 1663, 1664/1664.1, 1665, ISO and ICH Q3E; review and approving reports.
- Interpret and correlate extractables and leachable(s) data; perform risk assessments and toxicological evaluations (e.g., CASE Ultra software).
- Address customer and regulatory inquiries; ensure on-time delivery and compliance with cGMP, GLP, and QMS.
- Train and upskill team; maintain audit readiness for client and FDA visits.
General Manager-Operations (Head)
Cephas Life Sciences
04.2024 - 05.2025
- Developed and implemented operational strategies to improve efficiency, reduce costs, and maximize customer satisfaction.
- Established E&L capabilities for medical devices and pharma products; maintained GLP/cGMP environment and ISO/IEC 17025 compliance.
- Led a 15-member team delivering services in Nitrosamine, NDSRIs, and E&L; designed protocols and reviewed reports.
- Ensured incidents, deviations, and OOS were managed per QMS; maintained lab audit readiness.
- Designing E&L Protocol per regulatory guidance and reviewing and approving the reports.
- Routine monitoring method development/validation for nitrosamine via LC-HRMS,ICP-MS and GC-MS/MS.
- Engaged with new/existing customers; ensured on-time project delivery; provided team training.
Manager-ACL
Encube Ethicals Private Limited
04.2018 - 04.2020
- Built and led a 15-member E&L team for topical products and medical devices; set up and monitored GLP/cGMP environment.
- Designed E&L protocols based on primary/secondary packaging for multiple formulations aligned with USP–NF 1660/1663/1664, PQRI, and ISO guidance.
- Performed data interpretation and correlation for E&L;
- Performed elemental analysis by ICP-MS per ICH Q3D.
- Developed and validated nitrosamine methods using LC-HRMS and GC-MS/MS; supported routine analyses (Analytical Department).
- Routine analysis of Nitrosamine.
- Supported Analytical Development with method development/validation for finished products; reverse-engineering using multi-technique approaches.
- Reviewed instrument qualification, SOPs, STPs, and COAs; addressed USFDA queries for ANDA filings.
- Investigated and closed incidents, deviations, and OOS; reviewed analytical data; conducted toxicity evaluations using toxicology software.
Assistant Manager
Intertek India Private Limited
03.2016 - 03.2018
- Designed E&L protocols per regulatory and client requirements using appropriate solvent systems for diverse finished products and Manufacturing components.
- Executed extractables studies for various container–closure systems.
- Developed, validated, and quantified potential toxicants using LC-MS/MS and GC-MS.
- Identified unknown components in extractables/leachables via GC-MS and HPLC-DAD-MS/MS.
- Prepared E&L reports; authored and implemented SOPs/MOAs; maintained GDP/GLP.
- Addressed client clarifications; supported FDA/customer audits; managed incident/deviation/OOS closures.
- Impurity Identifications.
- Led team to streamline operations and enhance service delivery efficiency.
Junior Research Scientist
Piramal Enterprises Ltd
06.2015 - 03.2016
- API characterization; assay and related substances method development for pre-formulation and prototype batches via HPLC/UPLC.
- Validations per USFDA and ICH; forced degradation studies per ICH; related substances testing.
- Stability data compilation; initiated E&L activities for injectables (per PQRI/PODP); maintained GLP documentation.
- Analysis of pre & proto-type formulations.
- Initiated and implemented Extractables & Leachables (E&L) programs for injectable dosage forms, using LC-MS/MS and GC-MS/MS in accordance with PQRI and PODP guidance.
- Managed LNBs; calibrated/maintained HPLC and LC-MS/MS; prepared STPs/MOAs; reviewed development/validation protocols and reports.
Research Officer
Glenmark Pharmaceuticals Ltd
01.2012 - 05.2015
- Developed high-throughput, sensitive LC-MS/MS methods for NCEs, generics, and biomarkers; validated per USFDA Bio guidance.
- Quantified NCEs in diverse matrices for DMPK/pharmacology/toxicology assays.
- Performed in vitro assays (metabolic stability, CYP inhibition/phenotyping); identified Phase I/II metabolites via LC-MS/MS.
- Chromatographic separations and Identification of Phase-I and Phase-II conjugation metabolites by LC- MS/MS.
- Troubleshooting and maintained LC-MS/MS systems; performed formulation analysis; prepared bioanalytical reports and MOAs; documented daily work.
Research Associate
Glenmark Pharmaceuticals Ltd
04.2007 - 12.2011
- Developed high-throughput, sensitive LC-MS/MS methods for NCEs, generics, and biomarkers; validated per USFDA.
- Quantified NCEs in diverse matrices for DMPK/pharmacology/toxicology assays.
- Conducted metabolic stability studies; CYP inhibition using liver microsomes.
- Hands on Handling and dosing of Animals like Rat and Mouse.
- Hands on Bleeding of samples at appropriate time points for the PK study.
- Used Win-nonlin software for calculating the Pharmacokinetic parameters.
- Impurity Identification in finished products.
Education
Ph.D. - Chemistry
Vellore Institute of Technology
Vellore, Tamilnadu04.2026
M.Pharmacy - Pharmaceutical Analysis
Sri Ramakrishna College of Pharmacy
Coimbatore, Tamilnadu01.2007
B.Pharmacy -
C.L.Baid Metha College of Pharmacy
Chennai, Tamilnadu01.2005
Skills
- Thermo Scientific LTQ-Orbitrap mass Spec
- Thermo Scientific Q Exactive focus (HRAM)
- Thermo Scientific Triple quadrupole (LC-MS/MS)
- API 3200 QTRAP
- AB Sciex 4500 QTRAP
- AB Sciex 5500 QTRAP
- API 4000 triple quad
- Thermo Dionex Ultimate 3000
- Thermo Vanquish Core
- Shimadzu HPLC
- Waters UPLC
- Agilent 1200 series
- Shimadzu GC-MS-TQ8040
- Agilent Single Quad GC-MS
- Agilent Triple Quad GC-MS/MS
- Thermo Scientific TSQ 8000 series
- Thermo Scientific TSQ 9000 series
- Thermo Scientific Chemical Ionization MS (GC-MS)
- Thermo iCAP RQ (ICP- MS)
- UV-VIS, PDA, Fluorescence, ELSD & CAD Detectors
- Shimadzu HPTLC
- XRD
- Raman spectrometry
- Scanning Electron microscopy (SEM)
- DSC
- TGA
Accomplishments
- Proactively involved in three USFDA audit in zero 483 observations across the organization, NABL, CDSCO and MD-40 audits.
- Published a first research article on 'Development and Validation of a LC-MS/MS Method for the Profiling of Impurities Formed during Stress Study of Antifungal Agent- Efinaconazole (2022)'.
- Published a valuable review article on 'A Review on Analytical Methods of Anti-fungal Agents used for the Treatment of Onychomycosis (2024)'.
- Published a first research article on 'Determination of Efinaconazole in Plasma using Validated LC-MS/MS Technique' (2024)'.
- Best Paper award for 'Stability indicating method of Candesartan by RP-HPLC' at Biotechexellece-2007, Anna University in Chennai.
- Pro-actively involved in Glenmark's out-license molecule in the year 2011.
Certification
- ISO/IEC/17025:2017 (NABL)
Language Known
English
Hindi
Tamil
Timeline
General Manager
ALS (Formerly Analytical Solution)
05.2025 - Current
General Manager-Operations (Head)
Cephas Life Sciences
04.2024 - 05.2025
Manager-ACL
Encube Ethicals Private Limited
04.2018 - 04.2020
Assistant Manager
Intertek India Private Limited
03.2016 - 03.2018
Junior Research Scientist
Piramal Enterprises Ltd
06.2015 - 03.2016
Research Officer
Glenmark Pharmaceuticals Ltd
01.2012 - 05.2015
Research Associate
Glenmark Pharmaceuticals Ltd
04.2007 - 12.2011
M.Pharmacy - Pharmaceutical Analysis
Sri Ramakrishna College of Pharmacy
Ph.D. - Chemistry
Vellore Institute of Technology
B.Pharmacy -
C.L.Baid Metha College of Pharmacy
Core Competencies
· Extractable & Leachable (E/L)
· Nitrosamines, NDSRIs, GTIs
· Analytical support to product development
· Pre-clinical and Clinical bioanalytical
· De-formulation/Reverse Engineering
· LC-MS/MS, HRAM, GC-MS/MS, ICP-MS
· Impurity Profiling, Identification/Characterization
· Drug Metabolism and Pharmacokinetics (DMPK)
· Clinical BA/BE Studies (Pharmacokinetics/Bioanalytical)
· Regulatory Compliance (USFDA, ICH, ISO, GLP, cGMP)
Address for Communication
Bhoomi Orchid, Plot No-18/18A, Flat No-601, Sector-14, Kalamboli, Navi Mumbai, Maharashtra, India.
Personal Information
- Age: 42
- Father's Name: K. Srinivasan
- Date of birth: 21/12/1983
- Gender: Male
- Marital status: Married
Disclaimer
I solemnly declare that the information furnished herein is true to the best of my knowledge and belief.
S. Govindarajan