Position: Group Leader

Experience required: 12 15 years

Department: Analytical development

No. Position: Multiple

Qualification: M. Pharmacy in Analytical and M.sc (Chemistry)

Responsibilities:
Lead and manage Analytical Development activities for drug substances and drug products (OSD and/or injectables) for regulated markets (USFDA, EMA, etc.)
Provide technical guidance on analytical method development, validation, and transfer as per ICH guidelines
Review and approve analytical protocols, reports, and regulatory documents (AMDR, validation reports, STPs, ANDA/DMF sections)
Plan and oversee: Method development & validation activities, Stability studies and trending, forced degradation and impurity profiling, Specification setting etc
Drive troubleshooting, investigations, and root cause analysis
Ensure compliance with cGMP, GLP, and data integrity requirements
Implement Design of Experiments (DoE) and scientific approaches for method optimization
Manage project timelines, resource allocation, and deliverables
Collaborate with cross-functional teams (Formulation R&D;, QA, Regulatory Affairs, Production)
Support regulatory submissions and respond to queries from health authorities

📌 Group Leader Analytical Development Hyderabad (India)
🏢 Talentsphere Consulting
📍 India