RAMBABU B
Hyderabad
Summary
Results-driven pharmaceutical analytical research leader with 24 years of experience in Analytical R&D, Quality Control, and regulated laboratory environments. Led scientific teams in analytical method development and validation, supported global regulatory submissions, and established quality systems. Expertise includes IVRT/IVPT, dissolution sciences, chromatographic techniques, and GLP compliance.
Overview
4
4
Languages
5
5
Certifications
6
6
years of professional experience
Work History
Deputy General Manager – Analytical Development
Invitron Advanced Analytics Pvt. Ltd.
01.2020 - 01.2026
- Promoted to Deputy General Manager
- Direct analytical development, method validation, method transfer, process validation and instrument qualification activities.
- Directed analytical development, method validation, method transfer, process validation, and instrument qualification, ensuring alignment with project goals.
- Drove IVRT, IVPT, dissolution, cell-based bioassay, and immunogenicity study programs, enhancing regulatory compliance and data integrity.
- Lead a multidisciplinary organization comprising 3 Team Leaders and approximately 40 scientists.
- Led investigations, troubleshooting initiatives, CAPA implementation, and continuous improvement programs, fostering a culture of quality and accountability.
- Previous Roles: Group Leader – Analytical Research (Aleor Dermaceuticals) | Senior Research Scientist – Orbicular Pharmaceutical Technologies Pvt. Ltd. | Assistant Manager – Medreich Ltd. | Senior Analyst – Exela PharmSci Pvt. Ltd. (including assignment at Exela Pharma Sciences LLC, North Carolina, USA) | Quality Control Chemist – Medreich Sterilab Ltd.
Education
Ph.D. -
Datta Meghe Institute of Higher Education & Research
WardhaM.Sc. - Chemistry
Kuvempu University
KarnatakaB.Sc. - Chemistry
Sri Venkateswara University
Andhra PradeshSkills
Method validation
IVRT/IVPT Studies
Regulatory compliance
Quality Management Systems
Audit Readiness
Data Integrity
Technology Transfer
Process Optimization
Laboratory Operations
Strategic Project Management
Root cause analysis
Cross-functional Collaboration
Team Leadership & Mentoring
Certification
Lean Six Sigma Certification (2022)
Publications
- Method Development and Validation for Dissolution Testing, RJPBCS, Vol. 2, Issue 1 (2011)
- Determination of Valethamate Bromide in Pharmaceutical Dosage Forms by RP-HPLC Method
Key Leadership Achievements
- Successfully supported multiple US FDA audits and remote record review audits.
- Established and strengthened GLP-compliant analytical laboratories and quality systems.
- Led analytical support for product development, commercialization, scale-up, and regulatory submissions.
- Implemented process improvements enhancing laboratory efficiency, compliance, and project execution.
- Supported ISO 9001:2015 and NABL accreditation activities.
Timeline
Deputy General Manager – Analytical Development
Invitron Advanced Analytics Pvt. Ltd.
01.2020 - 01.2026
B.Sc. - Chemistry
Sri Venkateswara University
M.Sc. - Chemistry
Kuvempu University
Ph.D. -
Datta Meghe Institute of Higher Education & Research