The Sr. Project Lead Cell&Gene manages a team of several Project Leads and project managers who are responsible for the successful advanced development of late-stage cell and gene therapy products including transition from early phase development, technology transfer, validation (PPQ), submission and launch.
You will be managing 6-8 project leads that are responsible for 12-15 projects.
- Develops together with internal and client stakeholders a sound strategy for Cell&Gene leading to an integrated project plan that the team will execute against.
- Creates and implements project definitions, schedules, budgets, resource plans and objectives for late-stage cell and gene therapy product development program or multiple projects of high complexity across multiple sites.
- Provides technical expertise to and oversight of the company’s program team, including project management, process development, raw material characterization and qualification, sterility assurance, assay development and qualification/validation for raw materials, IPC and DP testing, process validation (PPQ) and justification for CPP/CQA, stability studies, any additional aspects relevant for quality assurance, quality control, supply chain and logistics, regulatory affairs and external testing organizations in regards to all CMC activities supporting the advanced development of a product through validation and commercialization.
- Leads technology transfer (if applicable), manufacturing process development and optimization, analytical method development, optimization and qualification, manufacturing, validation (process and analytical), material management and preparation of all source documentation required for regulatory submissions.
- Maintains a risk log for the program and develops, recommends and implements risk mitigation solutions.
- Provides ongoing reviews of the project status and identified risks of the project to internal and external stakeholders.
- Determines the need for and impact of changes in scope of project and makes and implements recommendations based on determinations.
- Works in conjunctions with team members and stakeholders to anticipate and manage changes to projects, such as but not limited to, technical requirements, business requirements and schedule
- Bachelor’s Degree in Scientific Discipline. Master degree preferred
- Highly proficient in global program and project management
- Minimum of 8 years experience in industry
- Working experience in a GMP-environment
- Experience in a CMO or CDMO organization would be an added value
- Proven experience influencing cross-functional teams in a highly matrixed environment
- Experience with Cell&Gene is preferred
- Preferably September or October, November also possible
- Permanent contract
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button. For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at email@example.com