Director Analytical Development
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Responsibilities
- You define and oversee all analytical development and GMP-compliant QC activities across small and large molecule projects, ensuring scientifically sound and phase-appropriate approaches.
- You plan and organize departmental activities and resources to consistently meet or exceed targets related to quality, productivity, timelines, and capacity.
- You drive the implementation of new analytical techniques, technologies, and digital solutions, in close collaboration with validation and maintenance, to expand the service offering and improve efficiency.
- You lead, coach, and develop Group Leaders and (Associate) Scientists, ensuring clear goal setting, strong performance management and continuous team development.
- You support the professional growth of team members through structured feedback, coaching, and targeted training initiatives.
- You collaborate closely with cross-functional stakeholders (Formulation Development, Production, Quality, Project Management) to resolve issues, define priorities, and translate these into clear, actionable plans.
- You provide strategic and technical input to client proposals, defining appropriate analytical strategies aligned with project scope and regulatory expectations.
- You are a member of and contribute to the local Management Team, actively supporting site strategy, operational decisions, and continuous improvement initiatives.
- You demonstrate the ability to strategically leverage AI and digital technologies to enhance Analytical Development performance, decision‑making, and innovation. You apply AI in a compliant, data‑driven manner to improve efficiency, quality and scientific insight, while guiding your team in responsible and effective AI adoption.
- You report to the Site Head of the Drug Development & Manufacturing Business Unit.
Requirements
- You hold a PhD or Master’s degree in a relevant scientific discipline and bring at least 10 years of experience in Analytical Development, including leadership experience.
- You have strong expertise in chromatographic techniques and dissolution, complemented by broad knowledge of physico-chemical and biological analytical methods (e.g., "Karl Fischer", electrophoresis, ELISA, microbiological methods, spectroscopy).
- You have solid knowledge of CMC development and applicable regulatory guidelines (ICH, EMA, FDA, etc.).
- You have a strong quality mindset and in-depth knowledge of GMP requirements.
- You combine a customer‑focused approach with a strong sense of ownership for timelines, budgets, and project delivery.
- You are proactive, flexible, and continuously seek opportunities for improvement and innovation.
- You demonstrate strong communication and reporting skills, with the ability to translate complex details into clear strategic insights.
- You thrive in a dynamic environment, effectively managing multiple priorities and stakeholders.
- You are a strong people leader with proven ability to build, align, and motivate teams across functions.
- You are proficient in MS Office; experience with Empower or similar systems is an asset.
- AI savviness.
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