Team Lead

The Team Lead Process R&D (API) will be responsible for leading a team of scientists/chemists in the development, optimization, and scale-up of robust and cost-effective synthetic processes for Active Pharmaceutical Ingredients (APIs). The role includes overseeing lab experiments, technology transfer, and ensuring regulatory compliance for process development projects.

Role & responsibilities

• Lead a team of scientists in developing and optimizing synthetic routes for APIs from lab scale to commercial scale.
  
• Design experiments (DOE) for process improvement, cost reduction, yield improvement, and impurity profiling.
  
• Monitor and review process parameters and data generated in the lab; provide technical guidance and troubleshooting support.
  
• Ensure development of scalable, safe, and reproducible processes aligned with GMP, safety, and environmental standards.
  
• Interface with cross-functional teams including Analytical R&D, Regulatory Affairs, Production, QA/QC, and Tech Transfer.
  
• Support scale-up activities in pilot plants and commercial manufacturing sites, including batch monitoring and documentation.
  
• Prepare and review technical documents including development reports, process protocols, risk assessments, and technology transfer documents.
  
• Guide team members in literature search (SciFinder, Reaxys), route selection, and patent landscape analysis.
  
• Maintain good documentation practices and ensure compliance with internal and external regulatory standards.
  

Key Requirements:

• M.Sc. or Ph.D. in Organic Chemistry / Medicinal Chemistry / Pharmaceutical Sciences.
  
• 812 years of hands-on experience in Process R&D for APIs in a reputed pharmaceutical or CRO/CDMO company.
  
• Strong background in organic synthesis, reaction mechanism, and impurity identification and control.
  
• Proven experience in scale-up and tech transfer to pilot plant or production scale.
  
• Familiarity with QbD, DOE, cGMP, ICH guidelines, and regulatory requirements (USFDA, EMA).
  
• Good communication, leadership, and project management skills.