Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
As a Drug Product Development (DPD) Technical Integrator you will work as a CMC team member representing DPD in global multi-disciplinary project teams. You will provide scientific expertise in vaccine development and contribute with your project/people management expertise to develop the current and future vaccine portfolio.
1. CMC team member
- Represent DPD in CMC vaccine teams from preclinical, tox, early development, late development and launch
- Lead all DPD aspects within CMC teams and be the point of contact
- Generation of appropriate risk management, mitigations and solutions
- Responsible for DP sections of regulatory submissions
2. Drug Product project leader
- Lead the DPD cross-functional sub-teams with SMEs
- Develop and update DPD project strategy
- Plan and execute project deliverables to the desired cost
- Coordination of regulatory activities
3. Member Technical Integrator team
- Identify common improvements and implements 'best practices'
- Expert owner in a specific area (ex. functional planning, stage gates, regulatory fillings...) and provide training
Key Performance Indicators
- Shape, create and deliver assigned DP project deliverables with high quality, within budget and timelines
- Leadership of drug product team(s) for one or more programs
- Timely management and escalation of risks affecting project deliverables
- Able to think and challenge beyond own expertise area in a constructive way
- Take quick action driven by scientific curiosity and strategic insights- Excel in communication and influencing key stakeholders
- Flexibility and adaptive to lead changes.- Facilitation of decision making process and ability to decide
- PhD or Master in biopharmaceutical sciences, engineering, biotechnology or analytical development
- Min. 4 years of experience within the pharmaceutical industry in the product development area
- People and project management experience
- Excellent communication skills
For more information please contact Carla Garcia at firstname.lastname@example.org or +21 (0) 20 658 98 01.