Senior E&L Lead, Analytical Chemistry & Regulation

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

Benefits offered by this job

Learning programs

Mentoring programs

Global leadership

Job summary

Capgemini Engineering is seeking a Senior Manager, Extractables & Leachables (E&L) to lead expert technical oversight across complex programs for pharmaceutical and medical device products. You will bridge analytical science, regulatory strategy, and cross-functional teams to drive technical excellence and operational performance.

Join a global leader in engineering services, leveraging advanced techniques (GC-MS, LC-MS, HRMS, ICP-MS) and regulatory experience (USP, ISO 10993, FDA/EMA) to shape

Qualifications

• Experience with extractables and leachables programs across pharmaceutical, medical device, and combination products.
• Hands-on experience with chromatographic and mass spectrometry platforms including GC-MS and LC-MS.
• Strong leadership in managing scientific or laboratory teams and ensuring cGMP compliance.

Responsibilities

• Providing technical oversight for E&L programs across inhalation, transdermal, injectables and medical devices.
• Leading method development, qualification, validation, transfer and lifecycle management of analytical methods.
• Guiding regulatory strategy and supporting submissions, inspections, and audits.
• Collaborating with manufacturing sites to ensure testing and release of critical materials.
• Driving Lean/Six Sigma initiatives for process improvements.

Skills

E&L expertise

Analytical chemistry

Leadership

Regulatory knowledge

Cross-functional collaboration

Education

B.S. or higher in Chemistry

Advanced degree preferred

Tools

GC-MS

LC-MS

HRMS

ICP-MS

Job description

Capgemini Engineering is seeking a Senior Manager, Extractables & Leachables (E&L) to lead expert technical oversight across complex programs for pharmaceutical and medical device products. You will bridge analytical science, regulatory strategy, and cross-functional teams to drive technical excellence and operational performance.

Join a global leader in engineering services, leveraging advanced techniques (GC-MS, LC-MS, HRMS, ICP-MS) and regulatory experience (USP, ISO 10993, FDA/EMA) to shape