Manager - Process Development & Equipment Selection API Manufacturing

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence.

Key Responsibilities:

1. Technology Transfer & Scale-up

• Lead the transfer of chemical processes from R&D to manufacturing.
  
• Evaluate and optimize process parameters for scale-up using mass and energy balances.
  
• Collaborate with Engineering for facility fitment, equipment readiness, and plant execution.
  

2. Equipment Selection & Sizing

• Analyse process requirements (reaction type, pressure/temperature profile, mixing, solvent use, etc.) to recommend suitable equipment.
  
• Select and size reactors, centrifuges, dryers, heat exchangers, condensers, and other equipment based on:
  
• Reaction kinetics and thermodynamics
  
• Process safety and control requirements
  
• Material compatibility and GMP compliance
  
• Evaluate batch vs. continuous processing options.
  
• Ensure scalability, containment, cleanability, and GMP compliance.
  
• Review P&IDs and layouts with Engineering and Production teams.
  

3. Process Optimization & Validation

• Conduct trials for equipment qualification and process optimization.
  
• Prepare and execute process validation protocols and reports.
  
• Lead QbD, DoE, and Process Analytical Technology (PAT) initiatives.
  

4. Documentation & Compliance

• Prepare/review equipment specifications, MFRs, BMRs, risk assessments, and validation documents.
  
• Ensure adherence to ICH Q8Q11, cGMP, USFDA, EUGMP, and other global guidelines.
  
• Support data generation for DMF filings and regulatory responses.
  

5. Cross-functional Collaboration

• Coordinate with R&D, QA, QC, Production, Engineering, EHS, and Regulatory Affairs.
  
• Provide technical training to operations and quality teams.
  
• Participate in internal/external audits and ensure compliance.
  

6. Continuous Improvement & Troubleshooting

• Analyse deviations and implement process/equipment modifications.
  
• Identify bottlenecks and recommend process/equipment upgrades.
  
• Drive cost-saving and productivity initiatives through efficient process/equipment utilization.
  

Required Qualifications & Skills

• Education:

  B.E./B.Tech/M.Tech in Chemical Engineering or M.Sc. in Chemistry.

• Experience:

  7 - 10 years in Technical Services, Process Engineering, or API Manufacturing.
• Strong understanding of process engineering and equipment design principles.
  
• Proven hands-on experience in selecting equipment for reactions, crystallization, drying, and filtration.
  
• Proficiency in PFDs, P&IDs, and risk mitigation strategies for scale-up.
  
• Working knowledge of process simulation tools (Aspen, ChemCAD, etc.) preferred.
  
• Familiarity with cGMP, regulatory requirements, and process safety norms.