Extractable and Leachables Leader

Job Description Summary

Job Description

Position Purpose

This role will partner extensively with the New Product Introduction and Product Teams in ISC, R&D and non-clinical services. The role is responsible for the extractable and leachable program for late-stage development and lifecycle management of approved products. This role requires a scientific and technical expertise as well as leadership, collaboration, innovation and networking.

Job Description / Responsibilities

Core Responsibilities

• Lead the Extractable and Leachable Program across the Integrated Supply Chain, setting strategy and executing policy to deliver a best-in-class program.

• Translate strategy into robust, competitive plans with optimized critical paths and clear decision points.

• Collaborate with Chemistry, Manufacturing Control, Primary and Secondary Materials Teams, Manufacturing Development, and Regulatory Affairs amongst others to develop robust control strategies.

Leadership

• Establish and lead highly collaborative working groups on extractables and leachables as per business needs.

• Act as an ambassador for the Integrated Supply Chain and Global Product Management Team.

• Lead, coach, and provide SME support during regulatory file authoring and interactions with authorities for submissions, variations, and license renewals.

• Role model partnership, transparency, and accountability for speed to market at the right quality. Demonstrate behaviours necessary for continuous improvement and optimized process execution.

• Establish internal and external networks to stay informed and prepare for future industry trends, clinical customer needs, technology opportunities and maintain and grow Team expertise.

• Demonstrate excellent organizational skills, including time management, priority setting, strong team working ethos, and ability to organize work to maximize output.

Technical

• Serve as the scientific liaison for the extractables and leachables program across our portfolio.

• Manage extractable and leachable third-party service providers to deliver high service levels to meet business requirements. Recognized expert in their discipline with a demonstrated track record of applying scientific knowledge across different business areas.

• Lead, prepare, review, and approve scientific and technical documents, including change scientific, technical reports, regulatory submissions, and responses.

• Conduct analytical risk assessments related to nitrosamines, PFAS, extractables & leachables, and elemental and organic impurities.

• Collaborate with global teams and third parties to support related laboratory studies

Qualifications and experience

• Ph. D desirable, M. Sc in Chemistry or related discipline with appropriate experience will be considered.

• Over 10 years in a pharmaceutical environment,

• Track record of managing scientific strategies for the business.

• Leadership of professional teams.

• 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).

• The ideal candidate has held a substantial role in new product introduction and or significant marketed product changes.

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

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviours

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everythingyou’dexpect from an organization with global strength and scale, andyou’llbe surrounded by career opportunities in a culture that fosters care,collaboration,and support.

Additional Information

Relocation Assistance Provided: No