Design Expert software
prasanth katakam
Guntur,AP
Summary
To pursue career in AR&D in an organization which provides a challenging work environment and allows me to grow both professionally and as an individual.
Dedicated Analytical Research with outstanding ability to analyze, gather, write, evaluate, and produce detailed reports on critical projects. Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Overview
16
16
years of professional experience
3
3
Certificates
3
3
Languages
4
4
years of post-secondary education
Work History
Sr. Scientist
Rising pharma specialities india pvt ltd.
Hyderabad
06.2015 - Current
- Evaluation, interpretation and taking decisions with respect to routine Analytical activities to move assigned projects to the next level
- Active participation in the project technical review meetings and communication with respect to analytical development, validations, and stability study evaluations for ANDA submissions
- Ensuring the product development activity from early stage to late-stage development
- Literature search for analytical method articles & Pharmacopical methods
- Handling of deficiency letters (IR/CR) for all kinds of dosage forms with in stipulated time from FDA for ANDA approval of drug product
- Approval of assay & related substances, dissolution/preservatives method validation protocols & reports.
- Analytical method development using QbD approach for Assay, related substances, preservative & dissolution with skilled QbD tools/software: Stat-Ease: Design-Expert & Minitab® software.
- Planning/monitoring and approval of analytical method development activities of assay & related substances, dissolution/preservatives methods
- Preparation and review of specification and standard test procedures for API and finished products
- Planning Routine and stability analysis and ensuring execution as per stability protocol for drug product
- Maintaining healthy environment in the team and cross functional teams
- People’s management: To ensure that the team members are current with knowledge, it is imperative that they continue to develop
- Pharmaceutical revisions and guidelines
- Maintaining the Team for the past eight years
- Established a robust safety culture within the lab, reducing incidents and maintaining compliance with regulatory standards.
Sr. Executive
SYNGENE INTERNATIONAL PVT LTD (A BIOCON COMPANY).
04.2014 - 05.2015
- Working with client of Baxter Global Research Center (BGRC)
- Analytical method optimization of Assay & Related substances
- Preparation of Method validation protocols and report for Assay & Related substances method
- Execution of method validation activity in cGMP environment
Sr. Associate
AGILA SPECIALITIES PVT LTD (A MYLAN COMPANY).
06.2012 - 04.2014
- Preparation of Method development reports and execution for Assay, Preservative & Related substances by HPLC for DP
- Preparation of Method validation Protocols, Reports and Execution for Assay, Preservative and Related substances by HPLC for DS/DP
- Execution of work for Analytical related Regulatory Queries
Research Chemist
GLAND PHARMA LTD.
04.2010 - 06.2012
- Method development and Validation of Assay and Related substances by HPLC
- Method development and Validation Residual solvents by GC
- HPLC analysis for the forced degradation, Stability and in process samples (Formulations)
- Supporting of Formulation deportment related studies (Stability studies, Compatibility studies)
Trainee Chemist
ANU’S LABORATORIES LTD.
08.2009 - 03.2010
- Distillation methods, Re crystallization procedures and Different Reagents preparation
- Reduction of time, cost reduction and solvent reduction
Education
PhD (Pursuing) -
Vignan’s Foundation For Science, Technology &Research
Guntur 07.2023 - Current
Master of Science - Organic chemistry
Andhra University
06.2007 - 07.2009
Skills
Research and experiments
undefinedCertification
Lean Six Sigma Green Belt (LSSGB), 2024
Software
Minitab Statistical software
Timeline
PhD (Pursuing) -
Vignan’s Foundation For Science, Technology &Research
07.2023 - Current
Sr. Scientist
Rising pharma specialities india pvt ltd.
06.2015 - Current
Sr. Executive
SYNGENE INTERNATIONAL PVT LTD (A BIOCON COMPANY).
04.2014 - 05.2015
Sr. Associate
AGILA SPECIALITIES PVT LTD (A MYLAN COMPANY).
06.2012 - 04.2014
Research Chemist
GLAND PHARMA LTD.
04.2010 - 06.2012
Trainee Chemist
ANU’S LABORATORIES LTD.
08.2009 - 03.2010
Master of Science - Organic chemistry
Andhra University
06.2007 - 07.2009
Languages
English
Telugu
Kannada
Personal Information
- Location Preference: Anywhere in India
- Date of Birth: 02/14/87
- Marital Status: Married
Disclaimer
I declare that the above mentioned details are true to the best of my knowledge.
Personal Information
- Location Preference: Anywhere in India
- Date of Birth: 02/14/87
- Marital Status: Married
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