Global Analytical Development Scientist – Hybrid

Capgemini Engineering; Diegem; Ibrido; EUR 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Capgemini Engineering is seeking an Analytical Development Scientific Integrator to own specifications for APIs, raw materials, intermediates, and drug products within a global supply chain. The role emphasizes regulatory alignment, method development, and cross-functional collaboration across governance bodies and regions.

You will drive harmonisation initiatives, manage diverse analytical activities, and support regulatory filings, balancing scientific excellence with Capgemini's business

Competenze

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences or related field required; a Master's/PhD preferred.
• At least 5 years' experience in analytical development or quality in pharma with hands-on HPLC/dissolution.
• Strong knowledge of regulatory frameworks (ICH Q6, GMP) and lifecycle/specification management.
• Proven ability to manage projects and communicate with international, cross-functional stakeholders.
• Experience with regulatory submissions and responding to agency queries is a plus.

Mansioni

• Own and manage full lifecycle of specifications for APIs and drug products.
• Lead global change management and harmonisation initiatives across the analytical portfolio.
• Oversee method development, validation, transfers, and quality investigations.
• Perform technical assessments and impurity management within analytical control profiles.
• Support regulatory filings and respond to queries with scientific rigor.
• Collaborate with global stakeholders across supply chain, regulatory, and quality.

Conoscenze

Project management

Stakeholder communication

Regulatory knowledge

Analytical thinking

Formazione

Bachelor's in Pharmacy/Pharmaceutical Sciences

Master's or PhD preferred

Strumenti

HPLC

Dissolution testing

Descrizione del lavoro

Capgemini Engineering is seeking an Analytical Development Scientific Integrator to own specifications for APIs, raw materials, intermediates, and drug products within a global supply chain. The role emphasizes regulatory alignment, method development, and cross-functional collaboration across governance bodies and regions.

You will drive harmonisation initiatives, manage diverse analytical activities, and support regulatory filings, balancing scientific excellence with Capgemini's business