Director Analytical Development

Jobtailor; Oost-Vlaanderen; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Jobtailor in Belgium seeks a senior leader for Analytical Development to oversee GMP-compliant QC activities across small and large molecule projects, ensuring sound, phase-appropriate analytical strategies.

You will lead and develop group leaders and scientists, drive new techniques and digital solutions, and collaborate with cross-functional teams to meet timelines, budgets and regulatory expectations. Strong focus on AI-enabled analytics and data-driven decision making.

Qualifications

• PhD or MSc in a relevant discipline with 10+ years in Analytical Development and leadership.
• Strong chromatographic and dissolution expertise; broad physico-chemical and biological analytics.
• Solid knowledge of CMC, ICH/EMA/FDA guidelines, and GMP.
• Customer-focused with ownership of timelines, budgets, and delivery.
• Proactive, flexible, and innovative with strong communication.
• Experience leading cross-functional teams.
• Proficient in MS Office; Empower experience is a plus.

Responsabilités

• Define and oversee analytical development and QC activities across projects.
• Plan departmental resources to meet quality, productivity, timelines and capacity.
• Drive new techniques, technologies, and digital solutions with validation.
• Coach and develop Group Leaders and Scientists; set clear goals.
• Collaborate with cross-functional teams to resolve issues and priorities.
• Provide strategic input to client proposals aligning with regulatory expectations.
• Support site strategy as part of the Management Team.
• Leverage AI and digital tech to improve performance with responsible adoption.

Connaissances

Chromatography

Dissolution

Leadership

Regulatory knowledge

Project management

Communication

AI literacy

MS Office

Formation

PhD or MSc

Outils

Empower

Description du poste

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.