Analytical Development - Scientific Integrator

Capgemini Engineering; Diegem; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Employee Recognition Program GetCelebr

FlexAbroad program

Hybrid working

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical development

HPLC

Dissolution

Lifecycle management

Regulatory guidelines

GMP compliance

Cross-functional communication

Formazione

Pharmacy degree

Master's or PhD preferred

Descrizione del lavoro

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 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 registrationsLeading global change management activities and driving harmonisation initiatives that have company-wide impact, while continuously improving analytical processesManaging a broad range of analytical activities including method development, validation, analytical method transfers, and quality investigations for marketed productsConducting technical assessments and scientific investigations related to the analytical control profile, including impurity management and compliance evaluationsSupporting 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 strategyCollaborating with global stakeholders across supply chain, regulatory, and quality functions, acting as a key project leader for analytical and specification-related initiativesYour profileA degree in Pharmacy, Pharmaceutical Sciences, Chemistry or a related discipline is required; a Master's or PhD is preferredAt 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 dissolutionStrong understanding of regulatory frameworks including ICH Q6 guidelines, pharmacopoeial requirements, and GMP compliance, with experience in specification management and lifecycle managementProven ability to manage projects and communicate effectively with international and cross-functional stakeholders, demonstrating confidence in both technical and scientific discussionsExperience with regulatory submissions and responding to agency queries is a strong advantageFluency in English next to French or DutchGood mobility to Brussels and BeerseWhat you'll love about working hereHybrid 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