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)
🏢 Talentsphere Consulting
📍 Hyderabad