Manager, Manufacturing Process Operations
Amneal Pharmaceuticals · Agra · onsite · Posted 1d ago
Undisclosed12–15 yrsfulltimeSourced from
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About this role
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 RD/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 RD, 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.
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.
Experience Preferably 12-15 years in Peptide/Pharmaceutical Manufacturing, with relevant experience in manufacturing operations and QMS.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
bprCGMPauditsChemistryCAPAManufacturing OperationsehsHAZOPprocess developmentEhs CompliancePharmaceutical SciencesManufacturing ProcessPharmaceutical ManufacturingManufacturingoperationscompliancePharmaceutical
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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