Essential Functions:
• Solid experience in solid-phase and liquid-phase peptide synthesis.
• Knowledge of hybrid technologies / Molecular Hiving preferred.
•Hands-on experience in process development of peptide pharmaceuticals.
• Exposure to scale-up processes will be an added advantage.
• Operate and monitor equipment used in various stages of API production such as
reactors, centrifuges, dryers, millers, sifters, etc.
• Ensure cleanliness and readiness of equipment before batch charging through
visual verification procedures.
• Maintain accurate records, including Batch Manufacturing Record (BMR), Batch
Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and
deviation reports.
• Execute batch operations strictly as per SOPs and GMP guidelines.
• Monitor and record process parameters in real-time to ensure adherence to
specifications and quality.
• Report and coordinate with Engineering for any equipment breakdowns during the
shift.
• Coordinate with QA for issuance and submission of documents and with the
warehouse for material movement.
• Handle raw materials, intermediates, and APIs, ensuring proper storage,
reconciliation, and documentation.
• Follow standard procedures for sampling and in-process testing of materials
and intermediates.
• Maintain cleanliness and good housekeeping in the designated manufacturing
area.
• Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report
abnormalities.
• Monitor and record environmental conditions like temperature, humidity, and
differential pressure in clean areas (Level-I, II, III).
• Perform daily verification and calibration checks of weighing balances.
• Participate in periodic equipment cleaning and preventive maintenance.
• Ensure proper handling and disposal of hazardous materials as per
environmental guidelines.
• Identify process deviations, malfunctions, or quality concerns and report them
immediately.
• Support continual improvement by suggesting ideas for optimi
📌 Manager, Manufacturing API (India)
🏢 Amneal
📍 India