Category

Description

Key Responsibilities

• Technical interface to external suppliers Establish partnership with external suppliers with focus to ensure and improve product process capability, keep the knowledge of process up to date and maintain the product in constant state of validation
• Support respective external suppliers with science- and risk-based approaches to ensure that product quality can be sustainably reproduced
• Product/ technical stewardship for defined key molecules Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given external suppliers
• Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site
• Assess impact of technical changes, assess technical feasibility and determine scope/ design of technical batches, challenge technical risk and business benefit of proposed technical changes
• Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations
• Lead / support root cause investigation of product and process failures. Effectively liaise with external suppliers to initiate and lead/support product/ process remediation/ improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development
• Maintain division and/or cross-division networks to share lessons learned and best practices related to process and technologies validation
• Support Validation Lead and Experts to assess need and plan validations, assess revalidation need

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