Nextenti Tech Private Limited
Website:
nextenti.ai
Job details:
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
Qualification
M Pharmacy and Msc Chemistry
Experience
12-15 years
Click on Apply to know more.