Director of Analytics Projects & Strategy

About the role

As Director AS&T Projects & Strategy – Analytical Lead you will drive the late‑stage protein pipeline within a global Analytics, Science & Technology department. You will act as the central liaison for all analytical activities, coordinating internal and external networks and representing analytics in interdisciplinary CMC teams.

Key responsibilities

• Serve as the single point of contact for CMC stakeholders and manage the full analytical portfolio.
• Coordinate analytical tasks across internal labs and external partners in line with the overall strategy.
• Define, align, and maintain the analytical control strategy across Regulatory Affairs, CMC, and Quality.
• Ensure compliance with US, EU, EMA, FDA, USP and Ph. Eur. guidelines.
• Own the analytical CMC Module 3 package (authoring, review, lifecycle management).
• Report progress, risks and delays to cross‑functional teams.

Required profile

• Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology or related field (PhD optional).
• 10+ years of biotech/pharma experience with strong analytical CMC background for mAbs.
• Proven track record in late‑stage antibody development, preferably including ADCs.
• Leadership and project‑management experience.
• Deep knowledge of US/EU regulatory standards, GMP, USP and Ph. Eur.
• Fluent English with excellent technical writing skills.
• Ability to work in intercultural, cross‑functional teams in a fast‑paced environment.

Required skills

• Analytical CMC development for monoclonal antibodies
• Antibody‑drug conjugate (ADC) analytics
• Regulatory submission preparation (PAI, BLA)
• Good Manufacturing Practices (GMP)
• USP and Ph. Eur. compliance

What we offer

• Flexible working hours and vacation account
• Digital learning platforms and leadership development programs
• Performance and talent development opportunities
• Inclusive culture with a voice at the table