Analytical Development Lead - Small Molecules

Capgemini; Diegem; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Employee Recognition Program GetCelebr

FlexAbroad program

Hybrid working

Job summary

Capgemini Belgium is seeking an Analytical Development Scientific Integrator to own specifications for APIs, raw materials, intermediates, and drug products, ensuring alignment with regulatory guidelines and registrations. You will drive harmonisation, manage method development/validation, transfers, and quality investigations across a broad portfolio.

You will collaborate with global stakeholders in regulatory, quality, and supply chain, contributing to continual process improvements and

Qualifications

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline.
• 5+ years of experience in analytical development or quality within a pharmaceutical environment.
• Hands-on knowledge of small molecule analytical methods (HPLC, dissolution).
• Strong understanding of regulatory frameworks (ICH Q6, pharmacopoeial requirements) and GMP compliance.
• Experience with specification lifecycle management and regulatory submissions is advantageous.

Responsibilities

• Own and manage the full lifecycle of specifications for APIs, raw materials, intermediates, and drug products.
• Lead global change management and harmonisation initiatives with company-wide impact.
• Manage method development, validation, transfers, and quality investigations for marketed products.
• Conduct technical assessments and investigations related to analytical control profiles and impurities.
• Support regulatory filings and respond to agency queries with state-of-the-art analytical strategies.
• Collaborate with global stakeholders across supply chain, regulatory and quality functions.

Skills

Analytical development

HPLC

Dissolution

Lifecycle management

Regulatory guidelines

GMP compliance

Cross-functional communication

Education

Pharmacy degree

Master's or PhD preferred

Job description

Capgemini Belgium is seeking an Analytical Development Scientific Integrator to own specifications for APIs, raw materials, intermediates, and drug products, ensuring alignment with regulatory guidelines and registrations. You will drive harmonisation, manage method development/validation, transfers, and quality investigations across a broad portfolio.

You will collaborate with global stakeholders in regulatory, quality, and supply chain, contributing to continual process improvements and