R C Bala Balaji Vobilisetti
Hyderabad
Summary
Accomplished professional with extensive expertise in analytical method development, project management, and cross-functional team leadership. Demonstrates strong performance standards and financial efficiency through effective budget control and strategic planning. Skilled in delivering clear, concise reports and presentations to senior stakeholders, ensuring compliance with GLP, ALCOA+ principles, and data integrity standards. Proven track record in coaching and mentoring teams, fostering a collaborative environment that enhances productivity. Career goals include leveraging technical mentorship skills to drive innovation in research methodologies and regulatory compliance.
Overview
19
19
years of professional experience
Work History
Chief -Industrial Project
SAIDAL GROUPE
01.2024 - 04.2026
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Proven successful at working within tight deadlines and a fast-paced environment.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Well experience in implementation of new technologies and updating of lab environment.
- Lead teams in method development and validation to ensure high-quality standards and regulatory compliance.
- Streamlined method transfer activities to enhance efficiency and effectiveness in processes.
- Actively involved in the procurement of new advanced instruments based on the project requirements.
- Proven ability to learn quickly and adapt to new situations.
- Resolved problems, improved operations and provided exceptional service.
- Review and approval of all the documents related to method development, method validation, and technology transfer.
Senior Principal Scientist
Aizant Drug Research solutions Pvt Ltd
12.2021 - 12.2023
- Organised and led analytical development group activities, guiding senior scientists and technical trainees through project execution processes and fostering professional development opportunities.
- Provided research and technical leadership within the Analytical Team on multiple projects, and outsourcing to contract laboratories.
- Planned and organised laboratory personnel of twenty on OSD and Liquid Injectables projects based on priorities, expertise, and timelines.
- Interviewed and recommended the hiring of laboratory personnel.
- Worked closely with quality and regulatory affairs to meet project technical document requirements, which led to successful product submissions.
Senior Analytical Development Specialist
Deva Holdings
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 and chromatographic purity.
- Reviewed laboratory notebooks and data in accordance with good documentation practices and GMP guidelines.
- Proposed weekly discussions of SOPS for clarity and ease in following procedures.
- Mentored junior scientist especially on impurity methods.
Executive
Mylan Labs
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
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 - M.SC (Analytical Chemistry)
DLR PG college
G.Mamidada, Andhrapradesh,India01-2007
Skills
Maintained strong performance standards across all core responsibilities and deliverables
Delivered clear, concise written reports, and confident verbal updates to senior stakeholders
Assessed and confirmed nitrosamine, genotoxic, and elemental impurities
QBd
GLP
ALCOA Principles
Cross-Functional Team Management
Coaching and Mentoring
Monitored and managed budget controls to ensure financial efficiency across operations
Good Documentation Practices
Skilled Technical Mentor
Communicated complex information through concise written documents and confident verbal presentations
Extensive Organization Skills and Time Management
Demonstrated strong leadership in team settings
Investigations and Corrective Action Execution
Expert Problem Solver and Troubleshooting
Authored GMP-compliant protocols, documentation and study reports for regulatory submissions
Implemented and tested input validation methods to streamline data transfer procedures
Analytical Method Development By DOE
Ensured compliance with data integrity and laboratory standards
Accomplishments
- Managed multiple projects from inception to completion including analytical method development, validation, and Technology transfer.
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
Languages
English, Hindi, Telugu
First language
Turkish
Upper intermediate
B2
Timeline
Chief -Industrial Project
SAIDAL GROUPE
01.2024 - 04.2026
Senior Principal Scientist
Aizant Drug Research solutions Pvt Ltd
12.2021 - 12.2023
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 - M.SC (Analytical Chemistry)
DLR PG college