Director AS&T Projects & Strategy

Responsibilities

• Represent analytics in interdisciplinary teams and act as the single point of contact for the CMC team and all relevant stakeholders
• Ensure successful management of all analytical activities and report progress, delays, and risks to cross-functional stakeholders
• Coordinate analytical tasks within the internal analytical network and with external partners in line with the overall analytical strategy
• Define and align the analytical control strategy across departments, including Regulatory Affairs, CMC, and Quality
• Ensure the proposed strategy aligns with health authority guidelines and regulatory requirements
• Take full ownership of the analytical CMC Module 3 package, including authoring, review, and lifecycle management

Requirements

• Advanced university degree in Biology, Chemistry, Pharmacy, Biotechnology, or a comparable scientific discipline (PhD preferred)
• 10+ years of industry experience within the biotech or pharmaceutical sector
• Strong background in analytical CMC activities for mAbs and/or experience in mAb QC or analytical development
• Proven track record in analytical late-stage antibody development, ideally including antibody-drug conjugates (ADCs)
• Demonstrated leadership and analytical project management experience
• Profound knowledge of US/EU, EMA, and FDA regulatory standards, CMC analytical development packages, and GMP
• Familiarity with USP and Ph. Eur. standards
• Fluent English with strong technical writing skills
• Ability to work in intercultural, cross-functional teams and thrive in a fast-paced environment

Preferred Qualifications

• Experience with pre-approval activities such as PAI, BLA preparation, and launch activities

Benefits

• Flexible working hours and vacation account
• Professional growth through digital learning, leadership development, and talent programs
• Company bike and mobility support via Deutschlandticket
• Employer-funded pension and childcare support

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovation and a commitment to improving global health.