Drug Product

Contract duration:

Key responsibilities:

• Lead technical expansion and capacity increase projects within Drug Product manufacturing to support production ramp-up.
• Provide technical input to project design, ensuring compliance with operational needs and regulatory standards (e.g., EU GMP Annex 1).
• Coordinate cross-functional teams and external suppliers, manage project governance, and ensure delivery on time and within scope.
• Develop and implement best-practice processes aligned with current industry and regulatory trends.
• Manage change control, troubleshooting, and deviations related to projects and equipment.
• Establish and update operational procedures in collaboration with manufacturing and quality functions.

Key requirements:

• Extensive technical experience in GMP manufacturing (Drug Product experience preferred).
• Proven track record of project coordination/management within pharmaceutical manufacturing.
• Experience with CAPEX projects and equipment qualification is an advantage.
• In-depth knowledge of cGMP and Annex 1 requirements.