Lead and manage the QC Chemical (Analytical) department for sterile injectable and peptide-based formulations.
Oversee analysis of Raw Materials, In-Process Samples, Finished Products, Stability Samples, and Packaging material samples as per pharmacopoeial and validated methods.
Ensure development, validation, transfer, and life-cycle management of analytical methods (HPLC, UPLC, GC, UV, Dissolution, KF, IC, LC-MS for peptide characterization).
Handle peptide-specific analytical testing including:
Peptide purity & impurity profiling
Molecular weight confirmation (LC-MS)
Sequence-related impurity evaluation
Aggregation studies and degradation profiling
Review and approve analytical protocols, reports, specifications, and standard testing procedures (STPs).
Ensure compliance with regulatory guidelines such as ICH, USP, EP, IP, USFDA, EMA, MHRA, WHO.
Lead stability program management (long-term, accelerated, and in-use studies) and trend evaluation.
Ensure proper calibration, qualification, and maintenance of analytical instruments (HPLC, GC, FTIR, UV, TOC, Karl Fischer, etc.).
Drive data integrity compliance (ALCOA+ principles) across QC systems and electronic data systems (LIMS, CDS, etc.).
Review and approve OOS, OOT, and laboratory deviations; lead investigations and CAPA implementation.
Coordinate with QA, Manufacturing, Regulatory Affairs, and R&D for timely product release and compliance adherence.
Ensure audit readiness and support regulatory inspections (USFDA, EMA, MHRA, WHO, and client audits).
Monitor laboratory operations for GMP compliance, safety, and productivity improvements.
Lead method transfers activities from R&D to QC for peptide and injectable products.
Develop and maintain QC departmental SOPs, specifications, and working instructions.
Ensure timely release of RM, PM, in-process, and finished product reports to support production timelines.
Drive continuous improvement initiatives in analytical workflows and laboratory efficiency.
End-to-end QC Analytical lifecycle for sterile injectables and peptide formulations
Advanced peptide characterization techniques (LC-MS, UPLC, impurity mapping)
Regulatory compliance under global health authorities (USFDA, EMA, MHRA)
Analytical method development, validation, and transfer lifecycle
Stability program design and statistical trend evaluation
Data integrity systems and electronic laboratory compliance (LIMS/CDS)
Cross-functional coordination in sterile manufacturing environment
