Analytical Development - Scientific Integrator

Capgemini Engineering; Diegem; Hybride; EUR 75 000 - 110 000; Plein temps

Résumé du poste

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

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Project management

Stakeholder communication

Regulatory knowledge

Analytical thinking

Formation

Bachelor's in Pharmacy/Pharmaceutical Sciences

Master's or PhD preferred

Outils

HPLC

Dissolution testing

Description du poste

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired bya collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s leading organizationsunlock the value of technology and build a more sustainable, more inclusive world.

Your role

As an Analytical Development Scientific Integrator, you will serve as the global owner of specifications for designated commercial small molecule products, acting as a central point of contact across the analytical portfolio within our client global supply chain. In this role you will play a key role in:

• Owning and managing the full lifecycle of specifications for APIs, raw materials, intermediates, and drug products, ensuring alignment with regulatory guidelines, compendia, and product registrations
• Leading global change management activities and driving harmonisation initiatives that have company-wide impact, while continuously improving analytical processes
• Managing a broad range of analytical activities including method development, validation, analytical method transfers, and quality investigations for marketed products
• Conducting technical assessments and scientific investigations related to the analytical control profile, including impurity management and compliance evaluations
• Supporting regulatory filings and responding to functional and technical queries, applying state-of-the art analytical strategies in line with scientific excellence and our client's business strategy
• Collaborating with global stakeholders across supply chain, regulatory, and quality functions, acting as a key project leader for analytical and specification-related initiatives

Your profile

• A degree in Pharmacy, Pharmaceutical Sciences, Chemistry or a related discipline is required; a Master's or PhD is preferred
• At least 5 years of experience in analytical development or quality within a pharmaceutical environment, with solid hands-on knowledge of small molecule analytical methods such as HPLC and dissolution
• Strong understanding of regulatory frameworks including ICH Q6 guidelines, pharmacopoeial requirements, and GMP compliance, with experience in specification management and lifecycle management
• Proven ability to manage projects and communicate effectively with international and cross-functional stakeholders, demonstrating confidence in both technical and scientific discussions
• Experience with regulatory submissions and responding to agency queries is a strong advantage
• Fluency in English next to French or Dutch
• Good mobility to Brussels and Beerse

What You'll Love About Working Here

• Hybrid working – We encourage flexibility when it comes to when and where work gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
• GetCELEBRATING – Our Employee Recognition Program is here to enable us to recognize inspiring people like you. The program appreciates both big and small wins, as well as the everyday efforts that help us all achieve the future we want. GetCelebrating makes the day-to-day feedback and kudos received from colleagues, exchangeable for prizes and gifts.
• FlexAbroad – Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.

Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology and people. With our strong heritage of nearly 60 years, we are a responsible and diverse group of 420,000 team members in more than 50 countries. We deliver end-to-end services and solutions with our deep industry expertise and strong partner ecosystem, leveraging our capabilities across strategy, technology, design, engineering and business operations. The Group reported 2024 global revenues of €22.1 billion.

Make it real | www.capgemini.com