Summary
Overview
Work History
Education
Skills
Accomplishments
Personality
Personal Information
References
Languages
Websites
References
Timeline
Generic

DHANALA NAGESWARA RAO

Hyderabad

Summary

Dedicated and results-driven professional with over 16 years of experience. I am seeking a challenging role in analytical research and development where I can leverage my skills and expertise to drive significant growth and development for the organization and my own career. I am eager to join a reputable organization that offers a stimulating and competitive work environment, opportunities for long-term growth, and a culture that fosters motivation and excellence. I am confident in my ability to make a meaningful contribution to the team and excel in my role.

Overview

16
16
years of professional experience

Work History

Head of Injectable AR&D (Assistant General Manager)

Chemo India Formulations
Hyderabad
07.2019 - Current
  • Responsible to provide end to end analytical support required for the development, filing and regulatory query support of all parentral products development programs.

Manager

Aurobindo Pharmaceuticals Limited Research Centre
Hyderabad
09.2017 - 07.2019
  • Responsible to provide end to end analytical support for the development of Generic Topical Solutions, Ointments, Creams and Gels.

Scientist

Dr. Reddy's Laboratories
Hyderabad
10.2016 - 09.2017
  • Responsible to provide end to end analytical support for the development of complex injections, simple injections and ophthalmic dosage forms.

Manager

Amneal Pharmaceuticals
Ahmedabad
05.2015 - 09.2016
  • Responsible to provide end to end analytical support for the development of complex injections, simple injections and ophthalmic dosage forms
  • Reverse engineering analytical method development and deformulation studies
  • Dissolution method development for Injectable suspensions, ophthalmic suspensions, microspheres and microspheres burst release
  • Well versed with bioassay
  • Actively participating in product development strategies ensuring the timely completion of projects
  • Method validation of different analytical methods by using various analytical techniques and Preparation of analytical method validation protocols & reports
  • Preparation and review of Test Procedures and ensuring compliance with the appropriate regulations and guidelines
  • Method transfer to Quality control Department
  • Investigation of OOE and OOS results
  • Training new hires on how to follow general laboratory procedures, use and maintenance of laboratory instruments and safety procedures.

Analytical Scientist

Novartis Healthcare
Hyderabad
10.2012 - 05.2015
  • Development of analytical methods for solid oral dosages, syrups and nasal solutions as per USFDA and ICH guidelines for related substances, assay, dissolution, Content Uniformity and Residue analysis
  • Validation of Analytical test procedure for related Substances, assay, dissolution, blend assay, content uniformity as per ICH & USP Guidelines
  • Carrying forced degradation studies to elucidate the degradation pathways and to indicate the stability of developed analytical methods
  • Developing new analytical methods and improving the existed methods
  • Characterization of In House Reference Standards and qualification of Working Standards against the compendial Reference Standards
  • Regular analytical support to R&D team by analyzing in process Samples, Finished Products and Stability Samples
  • Ensure that all work is Accurate, Precise, Properly documented and as per cGMP guidelines
  • Have a good awareness of cGLP, cGMP through continuous oral and visual Training
  • Laboratory note book data review for strict adherence to the compliance and Sop preparations.

Officer

Mylan Laboratories Limited
Hyderabad
10.2008 - 10.2012
  • Analytical Method Development and Validation (For Injections, Ophthalmic solutions, oncology products and solid oral dosage forms)
  • Analysis of in process Samples, Finished Products and Stability Samples of Drug Products
  • Reverse Engineering Analytical method Development (Excipients quantification) and Development of analytical methods for non chromophoric compounds by RI & ELSD
  • Actively participating in product development strategies ensuring the timely completion of projects
  • Vendor API Qualification and Method Verification
  • Calibration of analytical instruments like HPLC, GC, UV Spectrophotometer, KF Titrator, Analytical balance, pH meter
  • Dissolution Method Development, Compilation and mapping of dissolution profiles of Innovator and in house products
  • Good documentation practice by using Waters NuGenesis.

Education

Master of Science - Analytical Chemistry

Jawaharlal Nehru Technological University
Hyderabad, Telangana, India
01.2009

Bachelor of Science - Maths, Chemistry, Industrial Chemistry

Andhra University
Visakhapatnam, Andhra Pradesh, India
01.2005

Skills

End to end analytical support for the development of formulations

  • Peptide based complex injections, Olegonucleotide based injections, Iron based colloidal Injections, Polymer based long acting injections, nano suspensions, nano emulsions, n Simple Injections and other complex injections
  • Solid orals, Capsules and Caplets
  • Medical devices (vaginal drug delivery systems)
  • Creams and Ointments
  • Bio assay (LMWH)
  • Opthalmic Solutions
  • Syrups, Sachets
  • Nasal Solutions
  • Lozenges

Instrumental Knowledge:

  • Peptide characterization techniques (CD, Spectrofluorometer, SEC-UV, PPSQ, SV-AUC, Nano-DSC and LC-HRMS)
  • HPLC & UPLC with UV, PDA, RI, Fluorescence and ELSD detectors
  • GC (gas chromatography)
  • IC (Ion exchange Chromatography)
  • AAS & ICP-OES
  • Dissolution (USP-I,II,III,IV,V,VI,and VII)
  • IR Spectroscopy
  • Multimode micro plate reader
  • Rheometer
  • Zeta potential & Particle size analyzer
  • Mass spectroscopy (Agilent Q-Tof)

Skills

  • Project Management
  • Quality Management
  • Customer Relationship Management
  • Expense Control
  • Cross-Cultural Communications
  • Inventory Control
  • Budget Analysis
  • Relationship Building
  • Team Player

Accomplishments

  • Recipient of the “Award for hard work and dedication" shown in cross culture collaboration work in counterpart manufacturing site situated in Nyon, Switzerland.
  • Recipient of the “Award for above and beyond" for the successful completion of registration batches manufacture and analysis in counterpart manufacturing site within given stipulated time line situated in Nyon, Switzerland.
  • Recipient of the “Award for above and beyond" for the successful completion of all analytical method validation related to project completed in stipulated time frame.

Personality

Highly motivated with professional attitude and work ethics. Work well independently and as a part of a team. Friendly, reliable, very well organized creative self-starter and eagerness to learn newer technologies.

Personal Information

  • Passport Number: J4348848
  • Father's Name: Ankayya
  • Date of Birth: 08/15/1985
  • Marital Status: Married

References

Available upon request

Languages

Telugu
First Language
English
Proficient (C2)
C2
Hindi
Upper Intermediate (B2)
B2

References

References available upon request.

Timeline

Head of Injectable AR&D (Assistant General Manager)

Chemo India Formulations
07.2019 - Current

Manager

Aurobindo Pharmaceuticals Limited Research Centre
09.2017 - 07.2019

Scientist

Dr. Reddy's Laboratories
10.2016 - 09.2017

Manager

Amneal Pharmaceuticals
05.2015 - 09.2016

Analytical Scientist

Novartis Healthcare
10.2012 - 05.2015

Officer

Mylan Laboratories Limited
10.2008 - 10.2012

Master of Science - Analytical Chemistry

Jawaharlal Nehru Technological University

Bachelor of Science - Maths, Chemistry, Industrial Chemistry

Andhra University
DHANALA NAGESWARA RAO