General Manager - MSN Laboratories Private Ltd - Hyderabad, India
(2016-03)
Formulation Analytical R&D - Handling a separate Team of Analytical scientist's for the Product development especially various solid dosage forms of drug product, Ophthalmic Finished products, Complex Molecules (Peptides, Nucleotides, Iron Complex injectables and Microsphere, Liposome Formulations)
- Hands on experience in the Analytical exposure on the injectable/Complex injectable/Peptide molecule & in-active ingredients (Excipients)
- Preparation of Specification and Test procedure for various solid dosage forms of drug products, Ophthalmic products, Peptides and Injectables as per ICH Q6 and different regulatory bodies and customer requirements
- Analytical method development on various solid dosage forms of drug products, Ophthalmic products, Peptides and Injectables by using HPLC, GPC, Dissolution, Ion chromatography, Potentiometers and TLC techniques till product launch
- Monograph/Compendia evaluations for the commercialized market launch projects (USP, Ph.Eur, JP and IP etc)
- Reverse engineering Techniques development for the solid oral formulation and Complex injectables to prove (Q1, Q2 & Q3 approaches)
- Answering analytical queries from various health authorities e.g., Europe, US, TGA, ANVISA etc
- Co-ordination with QC Team, Regulatory and Quality Assurance department to achieve the better quality product
- Having good knowledge on change control, protocols, Deviations, CAPA, Investigations and Quality guidelines through QMS system
- Preparing protocols reports and review the analytical results in-line with the quality control procedures through e-DMS
- Transfer of Analytical Procedure to inter and intra contract manufacturing sites
- Conduct cleaning validation of swab and rinse samples
- Recruitment of new scientist for the various roles in the Analytical Development
Sr. Research Scientist-II - Apotex Research Private Limited - Bangalore, India
(2007-10 - 2016-01)
- Handled a separate Team as Product Life Cycle Management (PLCM) for commercialized drug substance and drug product
- Responsible for Analytical Method Validation team and look after analytical and cleaning method validation according to ICH guidelines assuring compliance with cGMP and GLP requirements
- Coordinate with cross functional teams to complete the validation projects with online documentation
- Preparing protocols reports and review the analytical results in-line with the quality control procedures
- Transfer of Analytical Procedure to inter and intra contract manufacturing sites
- Investigated deviations and out of specification cases (OOS) for identifying the root causes
- Closely co-ordinate with groups to maintain and archival of the validation documents
- Responsible for reviewing the analytical documents on day to day basis
Research Associate-IV - Aurobindo Pharmaceutical Research Centre - Hyderabad, India
(2003-07 - 2007-10)
Analytical method development and method validation in Dosage forms and Drug Substances
- Analytical method development and method validation in Dosage forms and Drug Substances by using HPLC'S, Ion Chromatography, HPTLC, UV/Visible Spectrophotometer and Wet Chemical Techniques
- Conducting stability study of Drug substances/Drug product as per ICH guidelines
- Generating method development protocols, COA's, Specifications for formulations
- Transfer of Analytical Procedure to Quality Control
- Perform pharmaceutical analysis to support product development
- Analysis of stability samples as per guidelines for dosage forms
- Analysis of various Active Pharmaceutical Ingredients as per Pharmacopeias and In-house methods
- Calibrations different laboratory instruments like HPLC, Dissolution testing Apparatus, UV/Visible Spectrophotometer and other Laboratory Equipments
