Senior Manager Extractables & Leachables - Life Sciences

Your Role

We are looking for a Senior Manager, Extractables & Leachables (E&L) to join our growing life sciences team. In this senior scientific leadership role, you will provide expert technical oversight across complex E&L and chemical characterization programs, supporting a wide range of pharmaceutical and medical device products. You will be a key interface between analytical science, regulatory strategy, and cross-functional teams, driving both technical excellence and operational performance.

In this role you will play a key role in:

• Providing technical oversight for extractables and leachables programs supporting inhalation products, transdermal systems, injectables, medical devices, and drug-device combination products, including leading chemical characterization studies utilizing advanced techniques such as GC-MS, LC-MS, HRMS, and ICP-MS.
• Leading the development, qualification, validation, transfer, and lifecycle management of analytical methods, while driving implementation of new analytical technologies and guiding investigations involving unknown compound identification and complex analytical challenges.
• Serving as a subject matter expert in global regulatory expectations for E&L and chemical characterization programs, including USP, ISO 10993, PQRI, FDA, EMA, and nitrosamine guidance, supporting product submissions, regulatory inspections, and customer audits.
• Leading analytical programs responsible for the qualification and clearance of plastic, elastomeric, and other critical components used in drug delivery systems, partnering with global manufacturing sites to ensure efficient testing and release of critical materials.
• Driving continuous improvement and operational excellence initiatives using Lean, Six Sigma, or equivalent methodologies, while collaborating cross-functionally with Manufacturing, Regulatory Affairs, Toxicology, Quality Assurance, and Commercial teams to support strategic decision-making.

Your Profile

• A Bachelor's degree or higher (Master's or PhD preferred) in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline, with a minimum of 10 years of analytical chemistry experience within pharmaceutical, medical device, combination product, or regulated healthcare industries.
• Demonstrated expertise in extractables and leachables, chemical characterization, and trace-level analytical testing, with extensive hands-on experience with chromatographic and mass spectrometry platforms including GC-MS and LC-MS.
• Minimum 5 years of leadership experience managing scientific or laboratory teams, with a strong understanding of cGMP laboratory operations, quality systems, and regulated product development environments.
• Strong knowledge of global regulatory frameworks including USP, ISO 10993-series, PQRI OINDP recommendations, and applicable FDA and EMA expectations, with experience supporting regulatory submissions and health authority interactions.
• Excellent technical writing, data interpretation, and communication skills, with the ability to present complex scientific information clearly to both technical and executive audiences, combined with strong cross-functional collaboration capabilities.

What you'll love about working here

• Own your Growth: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more. Our engineering academy offers more than 60,000 hours of training to support your professional development.

• Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.

• Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.