Senior Principal Scientist | Analytical Leader | Piramal Pharma – Apply Now!
Piramal Pharma Solutions (PPS) is seeking a highly skilled Senior Principal Scientist to join its Analytical team in Ahmedabad, Gujarat. This role offers an exciting opportunity to lead method development, validation, regulatory compliance, and analytical functions in a globally recognized Contract Development and Manufacturing Organization (CDMO). If you have a strong background in analytical chemistry, regulatory interactions, and team leadership, this is your chance to contribute to cutting-edge pharmaceutical research and innovation.
About the Company
Piramal Pharma Solutions (PPS) is a leading Contract Development and Manufacturing Organization (CDMO), providing end-to-end drug development and manufacturing solutions to pharmaceutical and biotech companies worldwide. With a strong presence in North America, Europe, and Asia, PPS offers comprehensive services across the drug life cycle, including drug discovery, process development, clinical trial supplies, and commercial manufacturing. The company specializes in highly potent APIs, antibody-drug conjugates, sterile fill/finish, peptides, and biologics, ensuring high-quality and regulatory-compliant solutions for global healthcare innovation.
Job Details of Senior Principal Scientist:
Job Posting: Senior Principal Scientist
Location: Ahmedabad, Gujarat, India
Job Description of Senior Principal Scientist:
- Monitoring 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 compliance with the lab SOPs, Computer system validation, and lab audits
- To ensure all project delivery on time and ensure 100% OTIF
- Perform an internal audit of the cross-functional department as per the QA schedule and share the findings with the team.
- Ensuring GxP in all levels of analytical works
- Review of specification, standard test procedure, Validation protocol, and report
- Review of all SOP, Guidelines, and qualification documents
- Monitoring overall analytical requirement flow and preparing the OPEX and CAPEX budget for the department
- Ensure Data Integrity
- Ensure GDP in the lab
- Implementation of digitization in Analytical and other cross-functional departments, i.e., AD, QA, IT, WH, Pilot plant, and Microbiology (ELN, Sample management, Inventory management, Stability management, etc.)
Education for Senior Principal Scientist: M.Sc./M. Pharm, Ph.D.
Required Skills: Analytical Function, Leadership and Team Handling, Nitrosamine
Keywords: Piramal Group, Senior Principal Scientist, Ahmedabad, Gujarat, India, Analytical Function, Leadership, Nitrosamine
