Associate Director, Projects & Strategy, Analytical Sciences & Technology

Responsibilities

• Represent the analytical function within cross‑functional project teams and act as the primary interface for the CMC team and other key stakeholders.
• Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
• Shape and align the analytical control strategy in close collaboration with functions such as Regulatory Affairs, CMC, and Quality, ensuring compliance with regulatory expectations and health authority requirements.
• Provide leadership and oversight for analytical activities, ensuring transparent communication of progress, timelines, risks, and challenges to relevant stakeholders.
• Maintain end‑to‑end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.

Requirements

• An advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific discipline, combined with over 10 years of experience in a regulated pharmaceutical environment.
• Broad experience within analytical functions, such as AS&T, Quality Control, or Analytical Development, with a focus on monoclonal antibodies (mAbs), multi‑specific antibodies, and/or antibody‑drug conjugates (ADCs).
• Strong track record in late‑stage analytical development and commercial support for antibody‑based products, ideally including experience with ADCs.
• Demonstrated leadership capabilities and solid experience in managing analytical projects.
• Deep understanding of relevant US and EU regulatory frameworks, including EMA and FDA requirements, CMC analytical development documentation, Good Manufacturing Practice (GMP), as well as compendial standards such as USP and Ph. Eur.
• Strong organizational skills, with the ability to analyze complex topics, break them down into manageable elements, and define timelines and dependencies accordingly.
• Proven ability to work effectively in intercultural, cross‑functional, and global team environments.
• Excellent communication and stakeholder management skills.
• Highly motivated, adaptable, and comfortable working in a dynamic, fast‑paced, and evolving environment.
• Experience supporting pre‑approval activities, such as Pre‑licensing Inspection (PLI) readiness, BLA preparation, and product launch activities, is considered an advantage.

Core Competencies

Demonstrates expertise in analytical development within the pharmaceutical industry, with a strong focus on monoclonal antibodies and regulatory compliance. Proven leadership in managing cross‑functional teams and analytical projects, ensuring alignment with regulatory frameworks and stakeholder expectations.