Senior Leader, Extractables & Leachables in Life Sciences

Capgemini Engineering; Wallonië; On-site; EUR 140,000 - 170,000; Full time

Benefits offered by this job

Learning assets access

Mentoring programs

Global leadership

Job summary

Capgemini Engineering is seeking a Senior Manager, Extractables & Leachables (E&L) to lead complex analytical programs across pharma and medical devices. You will coordinate chemical characterization, regulatory strategy, and cross-functional teams to ensure technical excellence and compliant product development.

In this senior role you will guide method development, validation, and lifecycle management, while advancing new analytical technologies and coordinating global quality and regulatory

Qualifications

• Bachelor’s degree or higher in Chemistry, Analytical Chemistry, or related field.
• Minimum 10 years of analytical chemistry experience in regulated industries.
• Leadership experience of 5+ years in scientific teams.
• Strong knowledge of USP, ISO 10993, FDA/EMA expectations.

Responsibilities

• Provide technical oversight for E&L programs across pharma devices.
• Lead method development, qualification, and lifecycle management.
• Interface with regulatory strategy and cross-functional teams.
• Support regulatory submissions, inspections, and audits.
• Drive continuous improvement using Lean/Six Sigma.

Skills

Scientific leadership

Regulatory knowledge

Cross-functional

Analytical chemistry

Method development

Education

Bachelor's degree or higher

Tools

GC-MS

LC-MS

HRMS

ICP-MS

Job description

Capgemini Engineering is seeking a Senior Manager, Extractables & Leachables (E&L) to lead complex analytical programs across pharma and medical devices. You will coordinate chemical characterization, regulatory strategy, and cross-functional teams to ensure technical excellence and compliant product development.

In this senior role you will guide method development, validation, and lifecycle management, while advancing new analytical technologies and coordinating global quality and regulatory