Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Timeline
Generic
R C Bala Balaji Vobilisetti

R C Bala Balaji Vobilisetti

Hyderabad

Summary

  • Experienced and resourceful Analytical Development Research Scientist offering outstanding skills in experimental design, Method development by QBd,method validation,Method verification, method transfer, and documentation for FDA approval.
  • A strong leader capable of managing technical personnel and training teams in research procedures and mentoring for achievement.
  • Analytical Chemist with more than sixteen years of experience working with teams of scientists in advanced research projects in GMP-regulated environments.
  • Extremely knowledgeable in overall laboratory function, maintenance, and project activities in relation to the availability of resources and timelines
  • Effective in written and oral communication skills to provide clear and concise information based on scientific research findings to team members and clients.
  • Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet organization goals.

Overview

16
16
years of professional experience

Work History

Senior Principal Scientist

Aizant Drug Research solutions Pvt Ltd
Hyderabad
12.2021 - Current
  • Preparation and review of regulatory documents like Photo-stability, comparative dissolution profile reports, residual solvents assessment reports, elemental impurity assessment reports, and nitrosamine impurity assessment reports.
  • Heading the Analytical Development (A&D) Group which includes Senior Scientists, Scientists, and Technical Trainees (I& II), total < 30 members.
  • Provided research and technical leadership within the Analytical Team on multiple projects and outsourcing to contract laboratories
  • Literature Search for development of analytical methods.
  • Planned and organized laboratory personnel of twenty on OSD and Liquid Injectables -projects based on priorities,expertise, and timelines .
  • Developed,validated, verified, and successfully transferred methods using HPLC by DOE and GC.
  • Mentored and supervised junior scientists in developing methods and troubleshooting.
  • Interviewed and recommended the hiring of laboratory personnel.
  • Worked closely with quality and regulatory affairs to meet project technical document requirements that led to successful product submissions.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

Senior Analytical Development Specialist

Deva Holdings
Cerkezkoy,Istanbul
10.2014 - 12.2021
  • Developed, validated and successfully transferred assay and impurity methods using HPLC for OSD , Derma and Injectable formulations.
  • Authored analytical methods, protocols and reports for drug analysis-assay, impurities, chromatographic purity, and chiral analysis
  • Reviewed laboratory notebooks and data per good documentation and GMP guidelines.
  • Proposed weekly discussions of SOPS for clarity and ease in following procedures
  • Troubleshoot impurity methods and provided workable solutions
  • Mentored junior scientist especially on impurity methods
  • Frequently presented on technical issues and solutions in group meetings

Executive

Mylan Labs
Hyderabad
06.2012 - 09.2014
  • Performed method development and method validation of OSD formulations using HPLC & UPLC
  • Authored methods and protocols for drug analysis-assay, related substances, and chromatographic purity for solid dosages.
  • Performed dissolution studies on solid dosage forms.
  • Provided in-process and stability testing support
  • Routinely calibrated balances and pH meters

Research Associate-IV

APL Research Centre-IV
Hyderabad
08.2007 - 06.2012
  • Responsible to perform the analytical developments for Assay, RS, CV (residue), BU/BA, CU/UOD and Dissolution by HPLC, UPLC and Dissolution apparatus.
  • Responsiblefor performing the Stability Sample analysis for Drug Products of various R&D batches, pilot and pivotal batches for ANDA filings.
  • Responsible to conduct the analytical method transfers from R&D to respective QC dept.

Education

Master of Science - Analytical Chemistry

DLR College
G.Mamidada
05.2007

Bachelor of Science - Mathematics,Physics And Chemistry

Sri Krishnaveni Degree College
Tanuku,Andhrapradesh,India
03.2005

Skills

Data Integrity and Lab Compliance

Analytical Method Development By DOE

Method Validation and Transfer

GMP Documentation, Protocol and Report Writing

Expert Problem Solver and Troubleshooting

Investigations and Corrective Action Execution

Team Leadership &Team Collaboration

Extensive Organization Skills and Time Management

Written/Verbal Communication
Skilled Technical Mentor

Good Documentation Practices

High-Performance Liquid Chromatography

Budget Controls

Coaching and Mentoring

Cross-Functional Team Management

ALCOA Principles

GLP

QBd

Assessment,Evaluation, and confirmation of Nitrosamine impurities, Genotoxic impurities, and Elemental impurities

Excellent Written and Verbal Communication

Accomplishments

  • Managed multiple projects from inception to completion including analytical method development, validation, and transfers
  • Served as subject matter expert in responding to FDA questions and internal audits regarding laboratory GMP compliance on operation procedures and processes
  • Coached and mentored junior analysts in resolving difficult technical challenges and recommended areas of training or literature that would enhance the needed skill or information
  • Successfully led the Analytical team in addressing compliance events relating to instrument qualifications, method validations, and analytical test results
  • Evaluated analytical development project activities based on the availability of budget resources, expertise, and set timelines for contract laboratories.


Additional Information

ANNEXURE Knowledge Purview

  • UPLC (Waters- with Empower 3 software).
  • HPLC (Waters & Shimadzu,) with Empower, LC-Solution
  • Gas Chromatography (Waters- with Empower 3 software)
  • UV-VIS Spectroscopy
  • Dissolution Apparatus – USP Type – I, II & IV. (Manual & Auto Sampler) –ElectroLab, Distek, LabIndia.


Languages Known:English, Hindi,Turkish and Telugu


Marital status : Married


Address:

FlatNo:104,Laxmijewel, Gangasthan,Dhoolapally,Hyderabad.


Declaration:

I hereby certify that the information provided is true to the best of my knowledge.


Sincerely,

R.C.Bala Balaji.Vobilisetti



Timeline

Senior Principal Scientist

Aizant Drug Research solutions Pvt Ltd
12.2021 - Current

Senior Analytical Development Specialist

Deva Holdings
10.2014 - 12.2021

Executive

Mylan Labs
06.2012 - 09.2014

Research Associate-IV

APL Research Centre-IV
08.2007 - 06.2012

Master of Science - Analytical Chemistry

DLR College

Bachelor of Science - Mathematics,Physics And Chemistry

Sri Krishnaveni Degree College
R C Bala Balaji Vobilisetti