ASAT Raw Material Manager

Responsibilities

• Establish quality standards, changes, and implementation for major raw materials and consumables as part of technical transfer activities.
• Provide Subject Matter Expert (SME) support for troubleshooting complex investigations and optimizing laboratory systems.
• Evaluate raw material and excipient testing strategies and participate in regulatory and customer audits to support QC activities.
• Drive the modernization of raw material testing by optimizing laboratory systems and implementing new technologies, including IT systems like Labware.
• Collaborate cross-functionally with QC Analytical Development, Project Management, Production, Process Science, and Quality Assurance.
• Lead risk assessments and implement mitigation strategies related to raw material testing and quality standards in cooperation with research experts.
• Support method development and validation according to ChP, USP, EP, and JP guidelines.
• Write, review, and approve data reports, OOS/OOT investigations, deviations, CAPA, and change controls.

Requirements

• Bachelor's degree with 8+ years of experience in a GMP environment, or a Master's/PhD with 4+ years of experience in a GMP environment.
• 5+ years of analytical testing experience, preferably in raw material testing within the biopharmaceutical industry.
• Deep understanding of risk-based approaches for raw material testing and risk assessment.
• Comprehensive knowledge of global drug regulations, including ICH, NMPA, FDA, EMA, USP, ChP, and EP.
• Proficiency in English (listening, speaking, reading, and writing).
• Strong communication and leadership skills with the ability to work effectively in cross-functional teams.
• Experience with Microsoft Office, Smartsheet, LIMS, and ERP systems (e.g., SAP).

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for cancer and other serious diseases.