We are seeking a highly motivated Project Manager to join as contractor the EU Site Management team in the Leiden.
Job description For our client dynamic fast growing Biotech company and is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Ou client brings a novel, decentralized cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access.
The Project Manager will be involved in the technical assessment of pre-selected manufacturers (CDMOs or bloodbanks), assessing the sites facility and licenses applicable to support the company's Decentral Manufacturing model, and will be responsible for coordinating the subsequent start-up and technology transfer activities. The Project Manager is the key contact person for the manufacturing site during site selection and technology transfer.
Responsibilities
Participation in site selection from a Tech Ops perspective, involved in:
- Assessment of the manufacturing facility and capabilities of a potential partner site, including site visits
- Assessment of the GMP readiness (e.g. licenses in place and required licenses to obtain)
- Providing site management team with the relevant information to enable well considered site selection including sequence, based on feasibility and capabilities
Act as project manager during the start-up and tech transfer phases by:
- Coordinating and support of implementation of the applicable licenses
- Coordinating equipment deployment and IOQ to the sites
- Generation of, maintenance of and oversight on the tech transfer planning
- Facilitating Project Team Meetings between CellPoint and the Point of Care manufacturing teams including minutes and follow-up on actions defined during these PTMs
- Reporting project status and timely escalation of changes and/or constraints to site management team
Liaison with the Point of Care manufacturing sites.
- Maintain relationship
- Monitor the manufacturing facility during clinical manufacturing operations
- Coordinate change where necessary (e.g. new product introduction, ramp up manufacturing rate)
Write procedures, deviations, change controls and CAPAs where appropriate
Requirements
- MSc of PhD degree in life sciences, biotechnology, or related discipline
- Strong and proven Project Management skills, including the capability to work with and develop tools to monitor and report on project status (e.g. SmartSheet, MS Project)
- Experienced in working with Contract Manufacturing Organisations in pharmaceuticals/biotech
- Knowledgeable on the CMC requirements applicable to ATMPs in clinical phase and beyond
- Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements, preferably within the field of gene therapy and ATMPs
- Be aware of the needs and perspectives of a Point-of-Care manufacturing site to translate these into well developed digitalized (training and support) systems
- Strong interpersonal, verbal and written communication skills
- Ability to be flexible with changing priorities
- Self-driven and can-do mindset, without compromising quality
- Fluent in English
Benefits
- Freelance contract - until EOY
- min 4 days/week on site in Leiden
Vacancy number: 24628
