Job DescriptionEssential FunctionsJOB DESCRIPTION- Strong 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 optimization, efficiency, and waste reduction.- Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions.- Adhere strictly to safety practices and use PPE as per company safety protocols.- Participate in emergency response activities such as managing spills or operational incidents.- Ensure timely inventory of plant/process-related consumables.- Review completed manufacturing records for accuracy, completeness, and compliance with SOPs.Additional Responsibilities- Support implementation of process improvement initiatives and lean manufacturing practices.- Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines.- Ensure readiness of the area for internal, external, and regulatory audits.- Support investigation and documentation of deviations, change controls, and CAPAs in coordination with QA.- Participate in cross-functional meetings to discuss production schedules, quality concerns, and improvement plans.- Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.- Train and mentor junior staff/operators on standard procedures and protected working practices.- Assist in preparation and review of SOPs related to manufacturing activities.- Support periodic review of equipment performance and suggest improvements for efficiency.- Ensure adherence to environmental and safety norms in chemical handling and waste disposal.- Actively participate in safety drills, risk assessments (HIRA), and incident investigations.- Coordinate with stores for timely availability of raw materials, consumables, and packing materials.- Report daily production updates to the shift in-charge or supervisor as required.Qualifications- Doctorate Degree, PhD– Organic Chemistry – Preferred- Master's degree, M. Sc – Organic Chemistry – Preferred- Doctorate Degree, PhD – Pharmacy- Preferred- Master's degree, M. Pharmacy- Preferred

📌 Manager, Manufacturing Api (Dahej)
🏢 Amneal Pharmaceuticals
📍 Dahej