A. Drive projects across all major stages of project life cycle, be it pre-feasibility, feasibility, development, transfer, ICH or regulatory (filings and queries).B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. ALCOA, KPIs, GxP, DQA/ QA/ QC, external and internal audits (Global, Local), OOx handling, investigations, RCA and CAPA.D. Team planning, training and development, goal settings, project… Show more A. Drive projects across all major stages of project life cycle, be it pre-feasibility, feasibility, development, transfer, ICH or regulatory (filings and queries).B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. ALCOA, KPIs, GxP, DQA/ QA/ QC, external and internal audits (Global, Local), OOx handling, investigations, RCA and CAPA.D. Team planning, training and development, goal settings, project budgeting, delivery time frame and resource mapping and candidate evaluation.E. Lead test method development, validation, verification and transfer.F. Lab operation management, sample management, chemicals and reagent management, lab safety, industrial hygiene, standard qualification, equipment maintenance and calibration, data handling, review and reporting.G. Exposure with SVP injections/ powders/ lyophilized products, LVP bags, combination devices e.g. PFS, API, intermediates, impurities, excipients, and packaging materials.H. Lead testing activities, content, performance, impurities, excipient content, residual solvents, dilution and reconstitution studies, elemental analysis, genotoxic, nitrosamines impurities, cleaning test method etc.I. Technical writing and reviewing skills, SOPs, WIs, GDs, file notes, change control, risk assessments, product specifications, protocols and reports, GTI/ Nitrosamine/ EI assessment documents.J. Highly engaged with CSV, URS, ER-ES, GAMP, RA, FAT/ SAT, IQ/ OQ/ PQ, DIA and RTM related activities Show less

A. Drove projects across pre-feasibility, feasibility and development phases with a 18 membered team, in a highly dynamic environment.B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. Lab operation management, sample management, chemicals and reagent management, lab safety, industrial hygiene, standard qualification, equipment maintenance and calibration, data handling, review and reporting.D. Oral solids,… Show more A. Drove projects across pre-feasibility, feasibility and development phases with a 18 membered team, in a highly dynamic environment.B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. Lab operation management, sample management, chemicals and reagent management, lab safety, industrial hygiene, standard qualification, equipment maintenance and calibration, data handling, review and reporting.D. Oral solids, solutions, suspensions and emulsions, ER/ MR tablets/ capsules, impurities, excipients and packaging materials.E. Testing activities, content, performance, impurities, excipient content, residual solvents, elemental analysis, genotoxic, nitrosamines impurities, cleaning test method etc.F. Technical writing and reviewing, SOPs, WIs, GDs, file notes, change control, risk assessments, product specifications, protocols and reports, GTI/ Nitrosamine/ EI assessment documents.G. Dissolution method development, similarity evaluations, ICH M9 Solubility evaluations, and Intrinsic Dissolution Rate (IDR) studies etc.H. Wide exposure with reverse engineering of dosage forms: (Q1/Q2) by API and excipients analysis, supported with solid state characterization tools. Show less

A. Pre-feasibility, feasibility, development, transfer, ICH and regulatory (filings and queries) supports with a 6 membered team.B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. ALCOA, KPIs, GxP, DQA/ QA/ QC needs, USFDA, ISO, Global, Local audits, OOx handling, investigations, RCA and CAPA.D. Team planning, training and development, goal settings, performance appraisals, project budgeting, delivery time… Show more A. Pre-feasibility, feasibility, development, transfer, ICH and regulatory (filings and queries) supports with a 6 membered team.B. Lab resource planning, budget phasing, manhour mapping, LEAN process, CAPEX evaluation, outsourcing and vendor evaluation.C. ALCOA, KPIs, GxP, DQA/ QA/ QC needs, USFDA, ISO, Global, Local audits, OOx handling, investigations, RCA and CAPA.D. Team planning, training and development, goal settings, performance appraisals, project budgeting, delivery time frame and resource mapping and candidate evaluation.E. Test method development, validation, verification and transfers.F. Lab operation management, sample management, chemicals and reagent management, lab safety, industrial hygiene, standard qualification, equipment maintenance and calibration, data handling, review and reporting.G. CSV - URS, ER-ES, GAMP, RA, FAT/ SAT, IQ/ OQ/ PQ, DIA and RTM related activities.H. Sophisticated studies like, Protein Binding, Molecular Dialysis, Salt stoichiometry, RF/RRF prediction etc.I. Liposomes, Combination Dosage Forms, oral solids, solutions, SVP injections/ powders/ lyophilized products, LVP bags, API, intermediates, impurities, excipients, and packaging materials.J. Testing activities - content, performance, impurities, free/ trapped drug in Liposomes, lipid analysis, Liposomal characterization, excipient content, residual solvents, dilution and reconstitution studies, elemental analysis, genotoxic, nitrosamines impurities, cleaning test method etc.K. Technical writing and reviewing, SOPs, WIs, GDs, file notes, change control, risk assessments, product specifications, protocols and reports.L. Degradation mechanism research, mass balance, preparative isolation and impurity characterization.M. Colorimetric Simulations, Quantitative CIE Colorimetry, L, a, b, ΔE Simulation, APHA index at various luminance and observers. Show less

A. Led projects at pre-feasibility, feasibility, development and transfer stages with a 4 membered team.B. Lab operation management, sample management, chemicals and reagent management, lab safety, standard qualification, equipment maintenance and calibration, data handling, review and reporting. C. DoE QbD based chromatographic test method developments, 2D/ 3D simulations and enantioselective chromatographic screenings. D. Knowledge of degradation mechanism research, mass balance… Show more A. Led projects at pre-feasibility, feasibility, development and transfer stages with a 4 membered team.B. Lab operation management, sample management, chemicals and reagent management, lab safety, standard qualification, equipment maintenance and calibration, data handling, review and reporting. C. DoE QbD based chromatographic test method developments, 2D/ 3D simulations and enantioselective chromatographic screenings. D. Knowledge of degradation mechanism research, mass balance and impurity characterization.E. Intensive dissolution method development, similarity evaluations, ICH M9 Solubility evaluations, and Intrinsic Dissolution Rate (IDR) studies etc.F Wide exposure with reverse engineering of dosage forms: (Q1/Q2) by API and excipients analysis, supported with solid state characterization tools.G. Accelerated Stability Assessment (ASAP) Models and DoE based Shelf-Life Prediction.R. Exposure to wide range of dosage forms, oral solids, solutions, suspensions and emulsions, ER/ MR tablets/ capsules, SVP injections/ powders, topical dosage forms e.g. creams and gels, API, intermediates, impurities and excipients.S. Led testing activities, content, performance, impurities, excipient content, residual solvents, cleaning test method etc.T. Technical writing and reviewing skills, SOPs, WIs, GDs, file notes, change control, risk assessments, product specifications, protocols and reports. Show less

A. Test method development, validation, verification and transfer.B. DoE QbD based chromatographic test method developments, 2D/ 3D simulations and enantioselective chromatographic screenings. C. Degradation mechanism research, mass balance and impurity characterization.D. Development and evaluation of Accelerated Stability Assessment (ASAP) Models and DoE based Shelf-Life Prediction.E. Exposure to peptide analysis, gel electrophoresis, SDS-PAGE and electrostatic blotting, amino… Show more A. Test method development, validation, verification and transfer.B. DoE QbD based chromatographic test method developments, 2D/ 3D simulations and enantioselective chromatographic screenings. C. Degradation mechanism research, mass balance and impurity characterization.D. Development and evaluation of Accelerated Stability Assessment (ASAP) Models and DoE based Shelf-Life Prediction.E. Exposure to peptide analysis, gel electrophoresis, SDS-PAGE and electrostatic blotting, amino acid sequencing.F. Knowledge of solid-state research, high throughput salt and solvate generation, solubility prediction (NRTL, ASPECT), characterization and physiochemical stability evaluation. Show less

Test method development, verification and transfer, routine stability analysis, wet analysis.Cleaning test method development.Plant support and regulatory query work.