Dhamodaram .K

Managing Analytical R&D team for projects in development of drug substance and drug product.
Managing impurity profiling for drug products.
Responding to IR and CR letters received from FDA for ANDA approval of drug product.
Successfully transfer analytical method from the Originating Lab to the receiving Lab (other Akorn Locations and CMO'S).
Trouble shooting for methods transferred to the receiving Lab.
Method Validation for drug substance and drug product as per cGMP.

Cleaning Validation for Drug Products.

Organize work of teammates involved in method development and validation of analytical methods .
Development of new analytical methods for Drug Product.

Cleaning Validation for Drug Products.
Stability studies for drug product.

Calibration and upkeep of analytical instruments.
Perform installation qualification, operational & performance qualification for new instrumentation.

Troubleshoot & perform maintenance on analytical Instrumentation.

Review and approval of Specifications, Standard test procedures, General testing procedures and Analytical raw data sheets (work sheets) through CITRIX LIMS (Caliber & Labware) and e-SPEC-ODS Management system (Bizapp software).

Review and approval of analytical documents like Analytical Method validation, method transfer protocols and reports.

Review and approval of Stability protocols, reports, summaries, and trends through Novatek stability program version 3.1.

Review of Analytical reports along with raw data (Batch release, In-process and Stability).

Handling and reviewing of Change controls, deviations, and OOS.

Conducting internal audits and GLP rounds in QC and Analytical development departments and preparing audit reports.

Review and approval of analytical documents like Analytical Method validation, method transfer protocols and reports, Specifications, Methods, COAs, Stability summaries of ANDA application submission products.

Review and approval of Specifications, Standard test procedures, General testing procedures and Analytical raw data sheets (work sheets).

Conducting internal audits and GLP rounds in Analytical development departments and preparing audit reports.

Review and approval of Specifications, Standard test procedures, General testing procedures and Analytical raw data sheets (work sheets).

Review and approval of Stability protocols, reports, summaries, and trends through LIMS.

Review and approval of analytical documents like Analytical Method validation, method transfer protocols and reports.

Development and validation of Analytical methods for
formulated pharmaceutical products.
Perform analytical testing using established in-house and USP analytical methods.
Evaluation of Active Pharmaceutical Ingredients for second sourcing.

Analysis of R&D samples and forced degradation studies.
Preparation and maintenance of Reference standards and working standards as per IP/BP/EP/USP and non-pharmacopoeia molecules.
Monitor calibration and maintenance of instruments and equipment.

Troubleshoot and perform maintenance on Analytical instrumentation.
Preparation of Instrument Operating Procedures for all instruments and equipment.

Analysis of Raw Material and Finished products as per Pharmacopoeia and In-house standards.
Hands on experience on instruments like HPLC, GC, IR, UV-VIS Spectrophotometer.
Analysis on Dissolution tester, Karl-Fischer apparatus, etc.
Media preparation, microbial limit test as per IP/BP/USP and other microbiological analysis.

Analysis of Raw Material, Finished product and Stability product.

Preparation and maintenance of Reference standards and working standards as per IP/BP/EP/USP and non-pharmacopoeia molecules.
Maintenance of stability records and monitoring stability studies.

Media preparation, microbial limit test as per IP/BP/USP and other microbiological analysis.