API Lead

As API Lead, you provide technical leadership for the development and manufacturing of precursors and active pharmaceutical ingredients (APIs) through external Contract Manufacturing Organizations (CMOs). You lead activities from early development and process optimization through scale-up, technology transfer, GMP manufacturing, to late-stage development As the primary technical interface between internal project teams and external partners, you ensure that quality, timelines, risks, costs, and technical deliverables remain aligned.

You apply your expertise in synthetic chemistry, GMP, and regulatory CMC requirements to guide technical decisions and resolve complex development and manufacturing challenges. Through strong stakeholder management, you bring internal and external experts together to deliver robust and compliant API manufacturing solutions.

Ideally this role is based in Oslo, where the team is based. However, we offer flexibility, and the role can also be based at our sites in the Netherlands (Eindhoven), or UK (Pollard Wood).

GE Health Care is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE Health Care Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

• Lead the development and manufacturing of APIs, precursors, and key materials at external CMOs from early development through commercialization.

• Act as the primary technical interface between internal project teams, CMOs, key suppliers, and other external development and manufacturing partners.

• Define development strategies, deliverables, timelines, risks, and priorities, and oversee process development, optimization, scale-up, technology transfer, and GMP manufacturing.

• Contribute to assessing selecting, qualifying, and onboarding CMOs and key suppliers based on technical capabilities, capacity, quality, cost, timelines, and risk, and monitor ongoing performance.

• Lead technical, quality, and manufacturing challenges, including deviations, investigations, change controls, and impurity-related issues.

• Define API starting material, characterization, and impurity-control strategies, including regulatory justification in line with applicable ICH guidelines.

• Prepare and review CMC documentation for manufacturing activities, and regulatory submissions.

• Collaborate across Quality, Regulatory, Analytical Development, Manufacturing, Supply Chain, Sourcing, IP, Legal, and project teams to ensure compliant execution in line with applicable GMP, regulatory, quality, and EHS requirements.

• PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or a related scientific or engineering discipline.

• Relevant experience in API, precursor, or pharmaceutical process development, including process development, scale-up, technology transfer, or manufacturing.

• Demonstrated experience managing CMOs or outsourced pharmaceutical development and manufacturing activities.

• Strong knowledge of GMP requirements, pharmaceutical development, and regulatory CMC expectations.

• Strong technical understanding of API characterization, analytical method development, impurity investigations, and impurity-control strategies.

• Experience preparing or…