Group Leader - Analytical development

Talentsphere Consulting; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Talentsphere Consulting in Hyderabad seeks a Group Leader for Analytical Development with 12–15 years of experience to lead and manage analytical development activities for drug substances and drug products (OSD and injectables) for regulated markets. You will drive method development, validation, and transfer per ICH guidelines while ensuring cGMP/GLP compliance.

You will review protocols, reports, and regulatory documents; plan stability studies, DoE, impurity profiling, and specification

Qualifications

• Experience in analytical method development and validation per ICH guidelines.
• Ability to transfer methods into manufacturing and QA environments.
• Experience with DoE and process optimization.
• Knowledge of regulatory requirements and documentation.
• Strong project management and cross-functional collaboration skills.

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

Skills

Analytical method development

Validation

DoE

cGMP

Regulatory documentation

Project management

Cross-functional collaboration

Education

M.Pharmacy in Analytical

M.Sc. in Chemistry

Job description

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