Senior API Development Lead - GMP, CMC & Tech Transfer

GE HealthCare (United States); Nederland; Híbrido; EUR 150.000 - 190.000; Jornada completa

Descripción de la vacante

GE HealthCare is seeking an API Lead to provide technical leadership for the development and manufacturing of APIs through external CMOs, from early development through commercialization. You will serve as the primary technical interface between internal project teams and external partners, ensuring quality, timelines, costs, and deliverables meet regulatory expectations.

The role supports development strategies, technology transfer, and GMP manufacturing while guiding regulatory CMC

Formación

• 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 supporting CMC documentation for regulatory submissions and health-authority interactions.
• Excellent written and verbal communication and stakeholder-management skills, with the ability to influence decisions and manage competing priorities in cross-functional and multicultural environments.
• Fluent in English, both written and verbal.

Responsabilidades

• 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.

Conocimientos

API process development

Scale-up

Technology transfer

CMC documentation

GMP knowledge

Regulatory CMC

Analytical method development

Stakeholder management

Communication

CMO management

Educación

PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or related

Descripción del empleo

GE HealthCare is seeking an API Lead to provide technical leadership for the development and manufacturing of APIs through external CMOs, from early development through commercialization. You will serve as the primary technical interface between internal project teams and external partners, ensuring quality, timelines, costs, and deliverables meet regulatory expectations.

The role supports development strategies, technology transfer, and GMP manufacturing while guiding regulatory CMC