Senior Manager Extractables & Leachables | Life Sciences

Capgemini

Software Companies

Diegem, (BE02) - Belgien

Director

Experteer Overview

In this Senior Manager role, you will provide expert scientific leadership for E&L and chemical characterization programs across pharmaceutical and medical device products. You’ll bridge analytical science, regulatory strategy, and cross-functional teams to drive technical excellence and efficient operations. You will lead complex characterization studies using GC-MS, LC-MS, HRMS, and ICP-MS, and guide method lifecycle management and new technology adoption. You’ll also partner on regulatory strategies and support global submissions and audits. This is a high-impact, globally-facing role at Capgemini Engineering, shaping critical materials testing and regulatory readiness.

Compensation / Benefits

world-class learning assets and programs
mentoring opportunities
professional growth and development
global, cross-functional collaboration
innovative engineering culture
leadership in AI, cloud, data capabilities

Responsibilities

Provide technical oversight for E&L programs across inhalation, transdermal, injectables, medical devices, and drug-device combinations
Lead chemical characterization studies using GC-MS, LC-MS, HRMS, and ICP-MS
Develop, qualify, validate, transfer, and lifecycle-manage analytical methods; implement new analytical technologies
Investigate unknown compounds and resolve complex analytical challenges
Serve as subject matter expert on global regulatory expectations (USP, ISO 10993, PQRI, FDA/EMA) and support submissions, inspections, and audits
Oversee qualification/clearance of plastic, elastomeric, and other components for drug delivery systems; coordinate with global manufacturing sites
Drive continuous improvement and operational excellence using Lean/Six Sigma; collaborate with Manufacturing, Regulatory, Toxicology, QA, and Commercial teams
Support strategic decision-making and cross-functional project directions

Key requirements

Bachelor’s degree with at least 10 years of analytical chemistry experience in pharma, medical devices, or regulated healthcare environments
Expertise in extractables and leachables, chemical characterization, and trace-level analytical testing
Hands-on experience with GC-MS, LC-MS (and related platforms)
Minimum 5 years of leadership experience managing scientific or laboratory teams
Strong knowledge of cGMP, quality systems, and regulated product development environments
Solid understanding of global regulatory frameworks (USP, ISO 10993-series, PQRI OINDP, FDA/EMA) and experience with regulatory submissions and health authority interactions
Excellent technical writing, data interpretation, and communication skills; ability to present to technical and executive stakeholders
Strong cross-functional collaboration abilities

Cross-functional collaboration Strong written and verbal communication Technical writing and data interpretation GC-MS LC-MS HRMS

Description

In this Senior Manager role, you will provide expert scientific leadership for E&L and chemical characterization programs across pharmac…

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