Group Leader-API - Analytical Development

Position:

Reporting to :Head-R&D

Location:Himachal Pradesh - Baddi

Age :

Qualification:

Experience:11-16 Years in APIs

Position Summary:

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. / 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.