Govindarajan Srinivasan

• Developed and implemented operational strategies to improve efficiency, reduce costs and maximize customer satisfaction.
• Leading a team of 15 members for providing quality service in the areas of Nitrosamine, NDSRI, and E&L activities.
• Establishment of E&L for Medical devices and Pharma products.
• Giving training and updating the knowledge of E&L for the team.
• Maintaining appropriate GLP and GMP environment.
• Discussion with new and existing customers for their new inquiries and ensuring on-time delivering of projects.
• Designing E&L Protocol and reviewing of reports.
• Ensuring all the incidents, deviations, and OOS adhere within the QMS appropriately.
• Readiness of the lab for anytime customer and FDA audits.
• Adequate training to the team members

DEPT: Advance Characterization Laboratory

• Leading a team of Extractable and Leachable for topical products, and medical devices.
• Developing a core E&L team
• Designing Extractable and Leachable protocol based on the Primary and secondary packaging materials for different finished formulations as per regulatory requirements like USP-NF 1663, 1664, 1665, PQRI, ISO guidelines, etc.
• Development of method and validation by various techniques for finished products.
• Interpretation and correlation of Extractable and Leachable data.
• Preparation of report and correlation with Leachables.
• Development and validation of related substance method as per ICH guideline.
• Elemental analysis by ICP-MS as per ICH Q3D guidelines
• Reverse Engineering by different techniques
• Method development and validation of Nitrosoamines using LC-HRMS and GCMS techniques
• Routine analysis of Nitrosoamines
• Preparation of SOP, STP and COA for release
• Setting up and monitoring the GLP environment
• Addressing the USFDA query related to ANDA filing
• Investigation, closing of incident and deviation reports for drug products
• Investigation and closing of Out of Specification (OOS) by various techniques
• Reviewing of analytical data from various techniques
• Toxicity evaluation of impurity using laser toxicity software

• Designing the Extractable and Leachable Protocols (E&L) as per regulatory guidelines and client requirements by different solvent systems.
• Conducting the Extractable study for different types of container closure systems for pharmaceutical products as per regulatory guidelines.
• Method development, validation, and quantitation for potential toxicity standards, which were used during the manufacturing of containers and closures in LC-MS/MS and GC-MS.
• Identification of unknown components in the extractable and leachable samples by using GC-MS, HPLC-DAD-MS/MS.
• Preparation of Extractable & Leachable reports.
• Preparation and Implementation of SOPs and MOAs
• Setting up, maintaining the Good Documentation Practices (GDP) and GLP in the laboratory.
• Addressing the client's clarification regarding the protocol and reports.
• Attending FDA, customer audits, and addressing the findings within stipulated time.
• Investigation of closing of incident, deviation forms and OOS (Out of specifications).

• API characterization
• Method Development for Assay and Related substances for a pre-formulation & proto type batches type by HPLC/UPLC
• Validation as per USFDA & ICH guidelines
• Conduction of force degradation study for Drug Substances as per ICH guidelines
• Initiating and performing related substance activity
• Compilation of stability data (Assay & RS)
• Analysis of pre & proto-type formulations
• Tech transfer to GMP site
• Initiation of daily activities to the junior's
• Initiation and implementation of Extractable and leachable activities by LCMS/MS & GC-MS/MS for the Injectable dosage forms (As per PQRI & PODP)
• Documentation as per GLP
• Creating and maintaining Lab note books (LNB)
• Calibration and maintenance of HPLC, LC-MS/MS
• Preparation of STP/MOA
• Review and maintenance of method development, validation protocol & reports

• Developed high through put and sensitive methods on LC-MS/MS systems for various NCEs, Generic compounds and Biomarkers
• Performed extensive validation as per US-FDA guidelines
• Quantified NCE's in different biological matrices for various DMPK, pharmacology and toxicology assays
• Performed high through put analysis of samples from In-vitro assays like Metabolic Stability, CYP Inhibition and CYP Phenotyping studies in Liver Microsomes
• Chromatographic separations and Identification of Phase-I and Phase-II conjugation metabolites by LC-MS/MS
• Responsible for Trouble shooting and routine LC-MS/MS maintenance, including the column testing, replacement and weekly cleaning
• Formulation Analysis of dosed samples for its accuracy
• Conducting stability experiment for formulation samples
• Preparation of Bio-analytical Reports
• Preparation of Method of Analysis (MOA'S)
• Documenting the daily work in the journal book

• Performed Metabolic Stability studies on different species
• Performed CYP Inhibition studies using Liver Microsomes
• Performed Plasma protein binding study using various methods like Rapid Equilibrium device (RED), Ultracentrifuge & High throughput device (HTD)
• 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