Manager, Manufacturing Process Operations

Amneal Pharmaceuticals LLC; Dahej; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Dahej, India seeks a seasoned leader for Peptide Upstream Manufacturing, with a focus on SPPS and QMS activities. You will drive cGMP compliant operations, supervise a biosynthesis team, and coordinate with R&D, QA, QC and supply chain to ensure timely GMP batches.

The role requires 12–15 years in peptide/pharmaceutical manufacturing, with extensive SPPS and QMS experience. A strong emphasis on data integrity, safety and regulatory readiness is essential.

Qualifications

• 12–15 years of Peptide/Pharmaceutical manufacturing experience.
• Experience in SPPS operations and QMS.
• Knowledge of cGMP, GDP and Data Integrity.

Responsibilities

• Peptide Upstream Manufacturing: Lead SPPS operations covering resin charging/swelling, Fmoc deprotection, amino acid coupling, washing, cleavage and filtration.
• Monitor yields, solvent/material consumption and equipment utilization.
• QMS Management: Own manufacturing-related deviations, CAPA, change controls, investigations and risk assessments.
• Review/approve SOPs, BMR/BPR, protocols and logbooks, ensuring GDP and timely QMS closure.
• Prepare for audits by customers, regulators and internal teams.
• Coordinate technology transfer, scale-up and equipment readiness for GMP batches.
• Lead cross-functional collaboration with R&D, QA, QC, Engineering and Procurement.

Skills

SPPS

GMP

QMS

Data Integrity

Safety

Education

B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech / M.Tech in Chemistry or related field

Job description

JOB DESCRIPTION

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.

Job Purpose

JOB DESCRIPTION

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.

Qualifications

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.