Senior Manager External Manufacturing Biologics

2 weeks ago

Mumbai, India SUN PHARMA Full time

Name of Organization Sun Pharmaceutical Industries Ltd.

Business Unit External Manufacturing and Supply Biologics

Location Mumbai, India

Position Sr. Manager/ Process Engineer- Biologics External Manufacturing

Reporting to Head – External Manufacturing and Supply Biologics


Primary Objective

The Sr. Manager/ Process Engineer will support the manufacture of Drug Substance and Drug Product (fill finish and secondary packaging) of biologics product. The activities range from tech transfer, technical process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and reviewing of DS/DP validation-related documents and key CMC sections of regulatory dossiers (different countries) are also required for this position.

Major Duties/Responsibilities

Responsible the operational activities at DS & DP CMO’s, and testing of DS/DP Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success. Support in development of specifications for raw materials, consumables, process intermediates and drug substance Preparation and review of documents such as CPV, risk assessments, technical reports, validation documents, deviation reports and regulatory modules. Responsible for Continuous Process Improvement and Process Optimization to reduce Cost of Goods Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven decisions are made In collaboration with Quality, Regulatory Affairs, Project management and analytical groups support the CMO operations to achieve on-time manufacturing in compliance with approved dossiers The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans. Other duties as assigned

Education

BE/BTech, MS or Ph.D. degree in (bio) chemical engineering, biotechnology.

Professional Experience

Doctorate degree with 1-3 years of related experience - or- Master's degree and 3-5 years of related experience - or- Bachelor's degree and 5-7 years of direct experience in Biologics GMP manufacturing Experience in cGMP in biologics is a must Experience in data handling and analysis Knowledge of statistical tools like minitab Knowledge of analytical testing methods and impact on product quality specifications is advantageous. Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams. Ability to influence internal and external stakeholders through scientific justifications

Skills & Abilities

Excellent interpersonal and communication, presentation skills Excellent organizational and project management skills, work well under pressure. Ability to thrive in a small group setting with limited administrative support

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