Production Chemist

Job Title

Production Chemist API

Job Summary

The Production Chemist – API is responsible for executing and monitoring chemical manufacturing processes for Active Pharmaceutical Ingredients in compliance with cGMP, safety, and quality standards. The role involves batch processing, documentation, equipment operation, and coordination with quality and engineering teams to ensure efficient and compliant production.

Key Responsibilities

• Execute API manufacturing processes such as reactions, crystallization, distillation, filtration, and drying
  
• Operate and monitor production equipment (reactors, centrifuges, dryers, etc.)
  
• Follow batch manufacturing records (BMRs) and standard operating procedures (SOPs)
  
• Ensure compliance with cGMP, EHS, and regulatory requirements
  
• Record accurate and timely production data and documentation
  
• Perform in-process checks and report deviations or abnormalities
  
• Assist in process optimization, yield improvement, and scale-up activities
  
• Coordinate with QA/QC for sampling, testing, and batch release
  
• Participate in investigations, CAPAs, and change control activities
  
• Maintain housekeeping and safety standards in the production area
  

Required Qualifications

• Bachelor’s or Master’s degree in

  Chemistry, Pharmaceutical Chemistry, or Chemical Engineering

• 0–5 years of experience in

  API or pharmaceutical manufacturing

  (experience level may vary by role)
• Knowledge of organic synthesis and chemical unit operations
  
• Familiarity with

  cGMP, SOPs, and regulatory guidelines

• Basic understanding of process safety and chemical handling
  

Preferred Skills

• Experience in regulated pharmaceutical manufacturing environments
  
• Knowledge of scale-up and technology transfer
  
• Strong documentation and data integrity practices
  
• Ability to work in shift operations, if required
  
• Team-oriented with good communication skills
  

Work Environment

• Manufacturing plant / cleanroom environment
  
• Use of PPE and adherence to strict safety protocols
  
• Shift-based work may be required
  
• Customize it for

  freshers

  or

  senior chemists

• Adapt it for

  US FDA / EU GMP–focused companies

  Role & responsibilities