API Lead: Pharma Development & CMO Manufacturing

MS0229 GE Healthcare AS

Oslo fylke

On-site

NOK 1,400,000 - 1,900,000

Full time

6 days ago
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Job summary

GE HealthCare is seeking an API Lead to provide technical leadership for development and manufacturing of APIs, precursors, and key materials with external CMOs. You will guide early development through GMP manufacturing and technology transfer, acting as the primary technical interface between internal teams and partners.

You will ensure quality, timelines, risks, costs, and deliverables are aligned, applying GMP and regulatory CMC requirements while leading stakeholder management across

Qualifications

  • PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, or Chemical Engineering.
  • Experience in API/process development, scale-up, or manufacturing.
  • Experience managing CMOs or outsourced pharma activities.
  • Excellent written and verbal communication with stakeholder management.
  • Fluent in English.

Responsibilities

  • Lead API, precursor, and material development at external CMOs.
  • Interface between internal teams and external partners.
  • Define development strategies, deliverables, timelines, risks, and priorities.
  • Oversee process development, scale-up, technology transfer, and GMP manufacturing.
  • Assess and onboard CMOs based on capabilities, capacity, quality, cost, timelines, and risk.
  • 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.

Skills

Stakeholder management
GMP knowledge
CMC documentation
Regulatory mindset

Education

PhD/MSc in Chemistry/Engineering

Job description

GE HealthCare is seeking an API Lead to provide technical leadership for development and manufacturing of APIs, precursors, and key materials with external CMOs. You will guide early development through GMP manufacturing and technology transfer, acting as the primary technical interface between internal teams and partners.

You will ensure quality, timelines, risks, costs, and deliverables are aligned, applying GMP and regulatory CMC requirements while leading stakeholder management across

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