We are seeking a highly motivated and energetic Extractable and Leachable Senior Scientist. Reporting to the E&L Leader and a member of the Global Product Management (GPM) Team, embedded within the wider Engineering and Transformation Team, this pivotal role will:

Serve as the lead scientific authority on extractables and leachable,
Steer the strategy for the extractable and leachable program across late-stage development and lifecycle management of approved products
Provide expert scientific guidance in collaboration with the New Product Introduction (NPI) teams, Integrated Supply Chain (ISC), Research & Development (R&D), and non-clinical services.
The Extractable and Leachable Senior Scientist’s expertise will directly support our strategic initiatives in precision healthcare revenue expansion and variable cost productivity management across the ISC function.

Responsibilities

Scientific Leadership & Expertise:

Act as the lead expert on extractables and leachable, offering scientific direction and serving as the primary liaison across internal and external stakeholders.
Partner effectively with NPI, ISC, R&D, and non-clinical teams to ensure scientific rigor and seamless integration of E&L strategies in product development.
Motivated by, and champions compliance and implementation of appropriate scientific advancements and regulatory changes.

Program Development & Management:

Develop, execute, and continuously improve the extractable and leachable program, ensuring robust risk assessments and adherence to regulatory standards.
Oversee the planning and implementation of extractables and leachable studies during late-stage product development as well as lifecycle management of approved products.

Collaboration & Stakeholder Engagement:

Build and nurture strong cross-functional relationships to align technical strategies with business objectives.
Work closely with the Engineering and Transformation Team to integrate innovative analytical methodologies that improve efficiency and product quality.

Regulatory and Documentation Support:

Provide scientific expertise for the preparation, review, and approval of documents such as technical reports, change controls, regulatory submissions, and audit reports.
Ensure all extractables and leachable initiatives comply with internal and external regulatory requirements and quality standards.
This is a key role to ensure compliance to global quality standards and will participate and or lead in assessment and implementation of revised standards. May represent GE Healthcare in external compliance or regulatory fora.

Strategic Impact:

Contribute to a high-growth, precision healthcare environment by optimizing processes and variable cost productivity.
Serve as a change agent and mentor within the organization, fostering a culture of scientific excellence, continuous improvement and supporting GE Healthcare Big Rock Priorities.

Technical Skills:

Strong analytical expertise, with a deep understanding of advanced extraction techniques and analytical instrumentation.
Familiarity with regulatory guidelines and quality standards relevant to extractables and leachable evaluations.

Leadership:

Excellent communication, collaboration, and mentorship skills, with a demonstrated ability to lead initiatives and drive operational change in a dynamic environment.
Strong growth mindset, excited for the future of GE Healthcare PDx.

Qualifications and experience

Education:

MSc/PhD in Chemistry, Pharmaceutical Sciences, or a related discipline, or equivalent experience.

Experience:

Extensive experience in extractable and leachable studies, including risk assessment and regulatory compliance, particularly within late-stage product development and lifecycle management.

Proven track record in a cross-functional, matrixed environment that supports high-growth initiatives.

Demonstrated ability to interface with diverse teams (NPI, ISC, R&D, and non-clinical services) and drive projects to successful outcomes.

Strong communication, influencing and coaching skills.

Ability to travel globally (10-20%)

Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)

Previous experience and training in Lean, problem solving tools and experience in data analysis and interpretation

Fluent in English and other languages are helpful.

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