API Lead – Global Pharma Manufacturing & CMO Partnering

GE HealthCare (United States); Noord-Holland; Presencial; EUR 120.000 - 180.000; 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, guiding activities from early development through scale-up and GMP manufacturing.

You will act as the primary technical interface between internal project teams and external partners, ensuring quality, timelines, risks, costs, and deliverables stay aligned with GMP, regulatory CMC requirements.

Formación

• PhD or MSc in a relevant chemical/engineering field.
• Relevant API/precursor process development experience.
• Experience managing CMOs or outsourced pharmaceutical development and manufacturing activities.
• Strong knowledge of GMP requirements, pharmaceutical development, and regulatory CMC expectations.
• Excellent written and verbal communication and stakeholder-management skills.
• 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 partners.
• Define development strategies, deliverables, timelines, risks, and priorities; oversee process development, scale-up, and GMP manufacturing.
• Contribute to selecting, qualifying, and onboarding CMOs and key suppliers based on technical capabilities and cost.
• Lead technical, quality, and manufacturing challenges, including deviations and impurity investigations.
• Define API starting material, characterization, and impurity-control strategies with regulatory justification.
• 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.

Conocimientos

Stakeholder mgmt

GMP knowledge

CMC coordination

English fluency

Educación

PhD in Organic Chemistry

Descripción del empleo

GE HealthCare is seeking an API Lead to provide technical leadership for the development and manufacturing of APIs through external CMOs, guiding activities from early development through scale-up and GMP manufacturing.

You will act as the primary technical interface between internal project teams and external partners, ensuring quality, timelines, risks, costs, and deliverables stay aligned with GMP, regulatory CMC requirements.