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.
• Manage 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 alignment with the overall strategy.
• Define and align the analytical control strategy across departments, including Regulatory Affairs, CMC, and Quality.
• Ensure the analytical strategy complies 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 monoclonal antibodies (mAbs).
• Proven track record in analytical late-stage antibody development, ideally including antibody-drug conjugates (ADCs).
• Profound knowledge of US/EU regulatory standards (EMA, FDA), CMC analytical development packages, and GMP.
• Familiarity with USP and Ph. Eur. standards.
• Fluent English with strong technical writing skills.
• Demonstrated leadership and analytical project management experience.

Preferred Qualifications

• Experience with pre-approval activities such as PAI, BLA preparation, and launch activities.
• Experience working in intercultural, cross-functional teams.
• Ability to manage complex challenges and plan associated timelines and interdependencies in a fast-paced environment.

Benefits

• Flexible working hours and a vacation account.
• Professional growth through digital learning, leadership development, and LinkedIn Learning.
• Health and lifestyle support including a company bike and job ticket (Deutschlandticket).
• Financial security through an employer-funded pension.
• Support for various life phases, including childcare.

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.