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Position Overview
We are seeking a motivated Technical Project Lead – Drug Product Manufacturing to drive key technical expansion and capacity-increase initiatives within our Drug Product operations. In this role, you will ensure our manufacturing capabilities scale in line with business needs while meeting all regulatory and operational standards. You will collaborate closely with cross-functional teams, external suppliers, and quality functions to deliver projects on time, in scope, and compliant with GMP expectations.
Key Responsibilities
- Lead technical expansion and capacity-increase projects within Drug Product manufacturing to support production ramp-up and operational growth.
- Provide expert technical input to project design and implementation, ensuring alignment with operational requirements and regulatory standards (including EU GMP Annex 1).
- Coordinate cross-functional teams and external suppliers, manage project governance, and monitor project progress to ensure timely and successful delivery.
- Develop, implement, and continuously improve best-practice processes that reflect the latest industry and regulatory trends.
- Oversee change control, troubleshooting, and deviation management related to equipment, processes, and project activities.
- Create, update, and maintain operational procedures in close collaboration with manufacturing, engineering, and quality assurance teams.
Key Requirements
- Minimum 2 years of technical experience in GMP manufacturing, preferably within Drug Product (fill-finish) operations.
- Demonstrated experience in project coordination or project management in a pharmaceutical manufacturing environment.
- Experience with CAPEX projects, equipment qualification (IQ/OQ/PQ), and facility readiness is a strong advantage.
- Solid understanding of cGMP regulations and EU GMP Annex 1 requirements.
- Fluent in English; German language skills are an advantage.
- Strong interpersonal and communication abilities; highly collaborative and results oriented.
- Agile mindset with resilience to handle pressure, changing priorities, and fast-paced project environments.
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