Director Protein & ADC Analytics

Core responsibilities:

• Providing technical analytical expertise with focus on linker-payload for early and late-stage development programs in compliance with GMP standards and in accordance with relevant industry guidelines
• Acting as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions
• Ensuring analytical method development, validation and transfer in alignment with overall project strategy & requirements
• Overseeing the creation/revision and approval of work instructions, transfer/validation documentation, and other supporting documents

Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Required skills and qualifications:

• Master’s degree or preferably Ph.D. in Analytical Chemistry or a related field, with at least 10 years of experience in an international, highly regulated environment
• Strong expertise in small molecule and ADC drug linkers analytical chemistry, including techniques such as HPLC, GC, mass spectrometry, NMR, and IR, with experience in assay development, validation, and statistical data analysis
• Proven experience in authoring CTD module 3 drug substance sections for regulatory submissions and filings
• In-depth knowledge of analytical control strategies, method validation, stability/degradation study design, and specification setting

Benefits include:

• Flexible hours and vacation account
• Digital Learning, Performance & talent development, leadership development, Apprenticeships, LinkedIn Learning
• Company bike
• Job ticket and Deutschlandticket for mobility
• Employer-funded pension and childcare support

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival, with a focus on addressing diseases with high medical needs like cancer and various infectious diseases.