Result-driven AR&D manager with 19 years of experience in leading the team on the conversion of HPLC methods to UPLC, method development & validation (HPLC, GC, Dissolution), Stability study, QMS, and Audit & Regulatory compliance.
Hi, I’m
HARIBABU SANKE
Mumbai
Summary
Overview
19
years of professional experience
Work History
Macleods Pharmaceutical Ltd. (R&D Centre)Mumbai
Manager- Formulation AR&D
07.2020 - Current
Job overview
- Leading a team to develop and validate analytical test procedures for US, EU, and WHO market
- Converted current HPLC methods to UPLC for the assay, RS, and Dissolution to increase throughput by 5 times
- Developed RS methods with very less run time for combination products by UPLC
- Managing the development of new analytical methods for drug products such as Dissolution, Assay, Related Substances, Residual solvents, etc. by HPLC, UPLC, and GC-HS.
- Optimized the RRF values for a few unstable and inter-convertible impurities
- Managing method transfer to QC for drug products
- Managing method equivalency study for pharmacopeial methods
- Successfully resolving method-related queries received from QC for effective and error-free implementation
- Reviewing and approving protocols, reports, investigations, and SOPs
- Imparting on-job training and providing troubleshooting support on various analytical techniques to the team
- Working proactively and collaboratively with cross-functional teams such as Formulation, QA, QC, and Project management to achieve project timelines.
Mylan (R&D Centre)Hyderabad, Telangana
Deputy Manager (AR&D)
04.2008 - 05.2020
Job overview
- Developed Related substances methods by UPLC for combination drug products with less run time
- Successfully identified the origin of the unknown peaks in Pregabalin for timely submission of FTF product
- Effectively used inorganic salt (sodium sulfate) to avoid gel formation (resulting in poor recovery) during Pregabalin ER tablets sample preparation
- Developed a particle size method for API by using the Malvern Particle size analyzer, to address bio-equivalence failure
- Developed assay and dissolution methods by UPLC for combination drug products with less than 5 min run time to increase productivity
- Conducted reverse engineering to quantify functional excipients present in reference product by using GC
- Designed a spreadsheet for tracking various activities in stability studies such as sample withdrawal, analysis, review, trend analysis, etc
- Designed a process to map column lifecycle from its receipt to discard.
- Worked effectively in fast-paced environments.
- Managed time efficiently in order to complete all tasks within deadlines.
Dr. Reddy's Laboratories Ltd.Hyderabad, Telangana
Sr. Executive (QC)
01.2006 - 04.2008
Job overview
- Analyzed raw material, and finished products in QC by using HPLC, GC, Dissolution, etc
- Achieved critical separation of unknown impurity from a known impurity
- This co-elution of unknown impurities with known impurity had caused several OOS results in the past
- Analyzed stability samples for submission and annual batches
- Completed method transfer for ANDA products
- Handled OOS, OOT, Incident investigations.
Neuland Laboratories Limited (API, Unit-I)Hyderabad
Chemist (QC)
09.2004 - 01.2006
Job overview
- Handled common instruments such as HPLC,UPLC, GC, UV, FTIR, KF, Auto-titrater
- Analyzed Raw material, Intermediates, and API for water content, wet analysis, and instrumental analysis
- Developed a titrimetric method for the assay of an intermediate to support process optimization
- Optimized glassware cleaning procedure to eliminate potential cross-contamination for sensitive techniques such as GC, and TOC.
Education
Andhra University
M.Sc - ANALYTICAL CHEMISTRY
01.2004
University Overview
Skills
- Method Validation
- Method Development
- Analytical method transfer
- Stability Study
- Cleaning Validation
- Team lead
- Empower-3
- Chromeleone
- Caliber LIMS
- TrackWise
- Time Management
- Team Supervision
- U/HPL, GC, KF, Partial size analyser, etc
Trainings
Trainings
- Trained on UPLC Method Development and Validation by Waters India
- Certified Internal Auditor by Broadbeach Innovations
- Completed "Quality Mastery Challenge" course from Pharma Growth Hub
- Effective Communication by Great Learning Academy
- Team leadership and Team management by Great Learning Academy
Languages
English
Proficient
C2
Telugu
Proficient
C2
Hindi
Advanced
C1
Marathi
Elementary
A2
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