Analytical Method Development & Validation

- Lead development of analytical methods for complex peptide molecules(HPLC/UPLC, LCMS, GCHS, Amino Acid Analysis).
- Implement Analytical QbD principles, including risk assessment (FMEA) and method lifecycle management.
- Perform and/or review method validation protocols, reports, and transfer packages.
- Define impurity characterization strategies (epimerization, oxidation, deamidation, peptide variants).

Tech Transfer & Manufacturing Support

- Lead analytical readiness for plant transfers; ensure smooth movement of methods to QC.
- Support PPQ batches, change control activities and analytical troubleshooting at plant.

Regulatory & Compliance

- Ensure strict GLP, GMP, and dataintegrity (ALCOA+) compliance across all analytical activities.
- Represent the analytical function during customer audits, regulatory interactions, and technical meetings.

Customer / Stakeholder Interface





- Act as the primary technical SME for analytical queries from global customers.
- Lead technical discussions, responses to client questions, and CMCanalytical sections when needed.
- Ensure customer expectations for timelines, reporting, and quality are consistently met.

Instrumentation & Asset Management

- Oversee calibration, preventive maintenance, and instrument qualification schedules
- Develop a multiyear instrumentation roadmap (LCMS upgrades, detector strategy, AAs analyzers).

Technical Competencies

- Expert in peptide analytical method development and validation (HPLC/UPLC, LCMS, GCHS).
- Understanding of peptide chemistry, degradation pathways, and impurity mechanisms.
- Robust knowledge of ICH guidelines, regulatory expectations, and global filing requirements.
- Handson experience with troubleshooting instrumentation and analytical problems.

📌 Senior Principal Scientist - Analytical Development (Peptide) (Maharashtra)
🏢 Piramal Pharma
📍 Maharashtra