Analytical Development - Scientific Integrator

Capgemini Engineering; Beerse; Hybride; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Hybrid working

GetCELEBRATING program

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Project management

Communication

Cross-functional collaboration

Analytical thinking

Formation

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry

Master's or PhD preferred

Outils

HPLC

Dissolution

Description du poste

# Analytical Development - Scientific IntegratorDiegemApply for this job* Permanent* Experienced Professionals* Manufacturing & Operations Engineering* ID 588665-en\\_GBChoosing 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 by a 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 organizations unlock the value of technology and build a more sustainable, more inclusive world.## Your roleAs 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.