Senior Principal Scientist

• Monitoring of analytical functions and ensuring real-time analytical support to the cross-function team to achieve the timeline of different projects
• Analytical method validation of drug substance and different dosage forms (i. e. tablets, capsule, oral solution, suspension, powder for oral solution, and injection) as per ICH & different regulatory guidelines by different analytical techniques
• Method transfer of analytical method as per different regulatory guidelines (USFDA, MHRA, ANVISA, Canada, and EU) for solid dosage forms (SR, ER, IR, MR, Chewable tablets, Minitablets, and capsules), Oral solution, Syrups, Suspension, and Lyophilized product
• Response to regulatory queries receive from USFDA, MHRA, EU, and other regulatory agencies
• Setting up the analytical Laboratory as per cGLP/cGMP norms, as well as establishing the system in tune with quality and regulatory requirements
• Method development, validations and stability samples for extractable and leachable studies by LCMS/GCMS/HPLC/ICPMS/IC
• Method development, Validation and Technology transfer for nitrosamines and other genotoxic impurities by LCMS/HRMS/GCMS
• Method development, validation, and technology transfer for elemental impurities
• Isolation, Identification and characterization of unknown impurities by Prep LC, LCMS, and NMR
• Interaction with different Piramal sites, and clients for different analytical support
• Discussion, Planning, Monitoring, and prioritizing the analytical activities. Interactive collaboration with client or internal Piramal sites to provide appropriate analytical support
• To ensure the compliance in the lab SOPs, Computer system validation and lab audits
• To ensure all project delivery on time and ensure 100% OTIF
• Perform internal audit of cross functional department as per QA schedule and share the finding with team
• Ensuring GxP in all levels of analytical works
• Review of specification, standard test procedure, Validation protocol and report
• Review of all SOP, Guideline and qualification documents
• Monitoring overall analytical requirement flow and preparing the OPEX and CAPEX budget for department
• Ensure Data integrity
• Ensure GDP in lab
• Implementation of digitization in Analytical and other cross functional department i. e. AD, QA, IT, WH, Pilot plant and Microbiology (ELN, Sample management, Inventory management, Stability management etc. )

Ensure appropriate training to team members as per their JD.

M. Sc. /M. Pharm, Ph. D.