Team Member - Manufacturing (Peptide)
Core
Execute batch manufacturing activities for complex APIs and drug master files in a GMP-compliant environment, ensuring strict adherence to safety protocols, SOPs, and quality standards.
Role type
Manufacturing Team Member (Peptide/Pharmaceutical)
Builds
Commercial and validation batches of complex Active Pharmaceutical Ingredients (APIs)
Domain
Pharmaceutical Manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Operation of critical equipment (reverse phase chromatography, Micro-wave reactor, Lyophilizer), MES software proficiency, GMP and GDP knowledge, equipment qualification and validation, process validation, calibration and preventive maintenance, clean room practices, SAP for quality notifications
Preferred skills
Understanding of Quality Management Systems (SOPs, URS, protocols), OEE optimization, regulatory compliance
Technologies
MES, SAP
Responsibilities
Execute batch manufacturing according to e-BMR instructions, coordinate with cross-functional teams (IPQA, MSAT, IPDO, Engineering, Warehouse, QC), maintain clean room conditions, perform equipment calibration and preventive maintenance, initiate quality and breakdown notifications, ensure regulatory compliance
Seniority
Mid-level, hands-on IC
