Global Analytical Specifications Lead (Hybrid)

Capgemini; Beerse; Híbrido; EUR 70.000 - 110.000; Tempo integral

Benefícios oferecidos por esta vaga

Hybrid working

GetCELEBRATING program

Resumo da vaga

Capgemini seeks an Analytical Development Scientific Integrator to own specifications for APIs, raw materials and drug products. You will drive harmonisation across the global supply chain, lead method development and validation, and support regulatory filings with scientific rigor.

You will collaborate with regulatory, quality and cross-functional teams, ensuring GMP and pharmacopoeial compliance while applying state-of-the-art analytical strategies.

Qualificações

• As part of the team, you own analytical specifications across APIs and drug products.
• Strong knowledge of regulatory guidelines and GMP compliance is required.
• Experience with regulatory submissions and agency inquiries is advantageous.

Responsabilidades

• Own the full lifecycle of analytical specifications for APIs, materials and products.
• Lead global change management and harmonisation initiatives impacting the company.
• Manage method development, validation, transfers and quality investigations.
• Support regulatory filings and respond to regulatory queries with scientific evidence.
• Collaborate with global stakeholders across supply chain, regulatory and quality.

Conhecimentos

Project management

Communication

Cross-functional collaboration

Analytical thinking

Formação

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry

Master's or PhD preferred

Ferramentas

HPLC

Dissolution

Descrição da vaga

Capgemini seeks an Analytical Development Scientific Integrator to own specifications for APIs, raw materials and drug products. You will drive harmonisation across the global supply chain, lead method development and validation, and support regulatory filings with scientific rigor.

You will collaborate with regulatory, quality and cross-functional teams, ensuring GMP and pharmacopoeial compliance while applying state-of-the-art analytical strategies.