Head of Analytical Development

Head of Analytical Development | Germany (Frankfurt Region)

A leading global pharmaceutical company is building out a newly created Analytical Development function and seeking an experienced Head to define and lead its strategic direction. This is a high‑impact leadership role sitting within the wider Pharmaceutical Development leadership team.

The Role

You will take ownership of all Drug Substance and Drug Product characterisation activities, spanning method development, validation, stability studies, and seamless transfer to Operations. You will lead a global, cross‑functional team and ensure the function supports the full development pipeline through to commercial launch.

Key Responsibilities

• Define and implement the global analytical development strategy across the full NCE pipeline from early research through to product launch
• Lead core functional areas including preformulation, in vitro dissolution, method development, and quality control
• Develop, validate, and transfer analytical methods supporting CMC submissions and regulatory filings
• Ensure compliance with global regulatory standards (GMP, FDA, EU)
• Drive innovation including accelerated stability models and predictive stability testing
• Build, develop, and mentor a high‑performing analytical development team

Requirements

• PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
• Proven experience in NCE or generics drug development is essential. Candidates without this background will not be considered
• Demonstrable expertise in preformulation across multiple dosage forms, including late‑stage development and commercial manufacturing
• Deep knowledge of analytical techniques: HPLC, in vitro dissolution, GC, MS, KF, FTIR
• Strong regulatory knowledge across GMP, FDA, and EU approval frameworks
• Minimum 3 years in a people management role leading cross‑functional or global teams
• Minimum 5 years of experience working within European pharmaceutical markets
• Fluency in English required
• Candidates must be willing and able to relocate to the Frankfurt region of Germany - this is a non‑negotiable requirement