Manager, Manufacturing Process Operations

Amneal Pharmaceuticals · Dahej SIR

Job Purpose

Lead Peptide Upstream Manufacturing, particularly Solid Phase Peptide Synthesis (SPPS), along with manufacturing QMS activities to ensure safe, compliant and timely execution in line with cGMP, quality, EHS and business/project requirements.

Key Responsibilities

Peptide Upstream Manufacturing: Lead SPPS operations covering resin charging/swelling, Fmoc deprotection, amino acid coupling, washing, cleavage and filtration. Ensure execution as per approved BMR/BPR, SOPs, process parameters, quality requirements and production schedules; monitor yields, solvent/material consumption and equipment utilization.
QMS Management: Own manufacturing-related deviations, CAPA, change controls, incident investigations, RCA and risk assessments. Review/approve SOPs, BMR/BPR, protocols, forms, checklists and logbooks, ensuring GDP, Data Integrity and timely QMS closure. Maintain readiness for customer, regulatory and internal audits.
Project & Equipment Readiness: Provide manufacturing inputs for URS, equipment/facility design and process requirements. Coordinate equipment procurement, FAT, SAT, installation, commissioning and qualification, including DQ/IQ/OQ/PQ as applicable, and ensure equipment readiness for engineering and GMP batches.
Technology Transfer & Scale-Up: Coordinate with R&D/Process Development for technology transfer, manufacturing feasibility and scale-up. Support engineering, demonstration, validation and commercial batches; identify scale-up risks, implement mitigation and transfer process knowledge to shop-floor teams.
Team Management: Lead, allocate and monitor the Upstream Manufacturing & QMS team. Ensure training and qualification in SPPS, GMP, QMS, troubleshooting and documentation, while driving Safety, Quality, Compliance, Productivity and Accountability.
Cross-Functional Coordination: Work closely with R&D, QA, QC, Engineering, Projects, Warehouse, Supply Chain, EHS, Validation and Procurement to ensure timely availability of raw materials, equipment, documents, utilities and manpower.
EHS & Compliance: Ensure safe handling of solvents, reagents, amino acids, resins and process materials. Participate in process risk assessments, HAZOP and safety reviews, and ensure timely closure of safety observations and corrective actions.

Department Peptide API Manufacturing Position Manager – Upstream Manufacturing opration Qualification B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech / M.Tech in Chemistry, Pharmaceutical Sciences, or related field Experience Preferably 12–15 years in Peptide/Pharmaceutical Manufacturing, with relevant experience in manufacturing operations and QMS.

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