Group Leader - API - Analytical Development

Position -

Qualification -

Additional Qualification -

Experience - 10-15 Years in APIs

Position Objective & Responsibilities

Position Summary:

The Group Leader – ARD will be responsible for leading the analytical research and development activities for new and existing API products. The role involves method development, validation, impurity profiling, stability studies, and ensuring compliance with regulatory requirements (USFDA, EMA, MHRA, etc.). The position demands strong technical expertise, leadership skills, and experience in managing a team of analytical scientists.

Key Responsibilities:

• Lead and manage a team of analysts/scientists in the Analytical R&D department.
• Plan, design, and execute analytical method development and validation for API and intermediates.
• Oversee characterization of impurities, degradation products, and reference standards.
• Ensure smooth transfer of analytical methods to Quality Control and Manufacturing units.
• Review and approve analytical data, method validation reports, and specifications.
• Conduct stability studies and support regulatory submissions (DMF, ANDA, etc.).
• Ensure all activities are performed in compliance with cGMP, GLP, and ICH guidelines.
• Troubleshoot analytical problems and provide technical support to manufacturing and QA teams.
• Coordinate with Regulatory Affairs for analytical documentation and data requirements.
• Maintain instruments such as HPLC, GC, LC-MS, GC-MS, UV, FTIR, and other analytical equipment.
• Provide training and mentoring to team members to enhance technical capability.
• Participate in internal and external audits and support compliance requirements.

Required Qualifications:

• Education:

  M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry or related discipline.

• Experience:

  Minimum

  10–15 years

  in Analytical R&D in the

  API / Bulk Drug

  industry, with at least

  3–5 years

  in a leadership role.
• Strong knowledge of analytical method development, validation, and stability studies as per ICH guidelines.
• Hands-on experience with HPLC, GC, LC-MS, ICP-OES, FTIR, UV-Vis, and other advanced analytical instruments.
• Thorough understanding of regulatory requirements (USFDA, EMA, MHRA, WHO, etc.).
• Strong leadership, communication, and project management skills.
• Experience in handling cross-functional coordination and analytical troubleshooting.

Desirable Skills:

• Exposure to impurity synthesis and structural elucidation.
• Knowledge of data integrity and ALCOA+ principles.
• Experience in authoring analytical sections of regulatory submissions.
• Proficiency in analytical software such as Empower, ChemStation, and LIMS.

Key Competencies:

• Excellent communication & Interpersonal skills
• Leadership
• Decision Making
• Good management skills