Summary
Overview
Work History
Education
Skills
Projects
Trainings And Internships
Certification
Websites
Languages
Timeline
Generic
Komakshi Sharma

Komakshi Sharma

Ahmedabad

Summary

I have over 4.5 years of experience and am currently working as an Associate Scientist in the biopharmaceutical industry, specializing in Drug Product Development with a strong focus on formulation science, analytical techniques, and process optimization. I have experience working with combination products, stability studies, process validation, drug development studies, and ensuring seamless integration of drug formulations with delivery devices.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Associate Scientist

Intas Pharmaceuticals Ltd
Ahmedabad
04.2024 - Current
  • Company Overview: Biopharma Division
  • Conduct and manage stability studies in coordination with cross-functional departments; compile and submit detailed technical reports.
  • Support the execution of comprehensive drug product development studies across various stages of formulation and process optimization.
  • Participate in batch manufacturing and process characterization of pipeline products.
  • Conduct process development and optimization studies for multiple drug molecules.
  • Execute formulation trials and contribute to optimization.
  • Prepare SOPs, stability protocols, technical reports, Stability Study Summary Reports (SSSR), Data recording sheet (DRS), BMR (Batch manufacturing record).
  • Collaborate with cross-functional teams to improve research workflows.
  • Perform routine instrument calibration and PV activities in compliance with scheduled timelines.
  • Conduct stability, compatibility, and performance testing for drug-device combinations.
  • Design and execute stability studies for lyophilized products and analyse post-lyophilization product quality, including moisture content and reconstitution performance
  • Biopharma Division

Research Associate

Intas Pharmaceuticals Ltd
Ahmedabad
02.2022 - 04.2024
  • Company Overview: Biopharma Division
  • Drafted SOPs, stability study protocols, technical reports, and Stability Study Summary Reports (SSSR).
  • Assisted in batch manufacturing and process development of drug products.
  • Conducted analytical techniques including HPLC, UV-Spectrophotometry, SoloVPE, and LPC, KF (Karl Fischer).
  • Supported in the execution of real-time, accelerated, and stress stability studies.
  • Assisted with calibration and maintenance of analytical instruments.
  • Prepared samples, formulation buffers, and mobile phases for analytical testing.
  • Biopharma Division

Trainee Research Associate

Intas Pharmaceuticals Ltd
Ahmedabad
08.2021 - 01.2022
  • Company Overview: Biopharma Division
  • Prepared formulation buffers and reagents for formulation and analytical experiments.
  • Supported in handling and labeling samples for formulation and stability studies.
  • Participated in routine stability and formulation development experiments.
  • Conducted basic tests such as pH measurement, osmolality, visual inspections and sub-visible particle count.
  • Helped prepare raw data summaries and organize reports under guidance.
  • Assisted in organizing lab files, safety records, and stability chamber logs, as per audit readiness requirements.
  • Consolidated experimental data for internal reports and analysis.
  • Biopharma Division

Trainee under DBT-BITP (Biotech Industrial Training Programme)

Intas Pharmaceuticals Ltd
Ahmedabad
01.2020 - 10.2020
  • Company Overview: Biopharma
  • Gained hands-on experience with key laboratory instruments including pH meter, osmometer, UV spectrophotometer, HPLC, filter integrity tester, Liquid particle count (LPC) and Dose IT pump.
  • Developed understanding of various in-process and final product tests conducted at different stages of drug product manufacturing.
  • Performed stability charging of drug product samples under different temperature and humidity conditions, in accordance with ICH guidelines.
  • Assisted in trend analysis and interpretation of stability and development study data.
  • Contributed to the preparation of reports and study summaries.
  • Assisted in the routine calibration and maintenance of laboratory equipment.
  • Biopharma

Education

Master of Science - Biotechnology

Shoolini University of Biotechnology and Management Science
Himachal Pradesh
01.2019

BSc(hons.) - Biotechnology

Sher-e Kashmir University of Agricultural Sciences and Technology
Jammu
01.2017

Skills

  • Stability studies
  • Microbial techniques
  • Molecular biology techniques
  • Analytical techniques
  • Analytical Data Interpretation
  • Trend Analysis
  • Formulation development
  • Process optimization
  • Cross-functional Team Collaboration
  • Combination products development
  • Device functionality

Projects

Conducted research on the 'Antimicrobial, Phytochemical, and Antioxidant Properties of Medicinal Fern Asplenium dalhousie' as part of a project at Shoolini University, HP, in 2018-19.

Trainings And Internships

  • Completed 2.5 months of practical training in the Department of Biochemistry on 'Electrochemiluminescence Technology for Assessing Thyroid Levels using a Fully Automated Analyzer' at Govt. Medical College, Jammu, in 2017.
  • Gained 1.5 months of hands-on experience in the Department of Microbiology, learning basic microbial techniques at Govt. Medical College, Jammu, in 2017.
  • Completed 2 months of training on 'Isolation and Characterization of Microorganisms for Bioactive Production' at CSIR-IIIM (Indian Institute of Integrative Medicine) in 2018.

Certification

  • Methods of Molecular Biology
  • PCR and Real time PCR

Languages

  • English
  • Hindi
  • Punjabi

Timeline

Associate Scientist

Intas Pharmaceuticals Ltd
04.2024 - Current

Research Associate

Intas Pharmaceuticals Ltd
02.2022 - 04.2024

Trainee Research Associate

Intas Pharmaceuticals Ltd
08.2021 - 01.2022

Trainee under DBT-BITP (Biotech Industrial Training Programme)

Intas Pharmaceuticals Ltd
01.2020 - 10.2020

Master of Science - Biotechnology

Shoolini University of Biotechnology and Management Science

BSc(hons.) - Biotechnology

Sher-e Kashmir University of Agricultural Sciences and Technology

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Komakshi Sharma