Facility Lead Cryopreservation
il y a 2 semaines
Given the central role in the organization, colleagues that able to naturally foster strong partnerships with other groups are most influential, e.g.
in reducing our supply base and achieve operational excellence goals.Responsibilities:
- Drives the startup and seamless campus integration of the Beerse cryopreservation facility: People, Processes, Infrastructure
- Accountable for successful technical, inspection and operational readiness
- Leads the cryopreservation facility daily operations
- Acts as primary point of contact and maintains relations with Beerse and Ghent campus teams as well as the global autologous therapy SC organization
- Develops working knowledge of Information Technology, Logistics and medical knowhow
- Drives issues management and risk management
- Designs and maintains metrics to monitor facility performance
- Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external)
- Conducts and oversees change management related to process and equipment changes that could impact the final product
- Ensures short cycle times contributing to reduced apheresis to release time
Qualifications:
- A master's degree in a relevant field such as medical biology or similar
- Handson (cell) laboratory, tissue establishment or cell banking experience is highly preferred
- A minimum of 7 years of direct or indirect people leadership experience in a pharma environment is required
- In depth knowledge of cGMP and the EU Tissue and Cell Directives is required, as well as knowledge of the applicable Belgium laws (such as wet MLM)
- Excellent people leader with proven track record in building and developing teams
- Proven track record in effective stake holder management in Belgium
- Ability to effectively work in local teams and enjoys a matrixed multistakeholder environment
- Project Management skills and the ability to interface crossfunctionally with clinical, supply chain and manufacturing personnel is required
- Ability to communicate clearly and effectively with all levels of the organization
- Ability to summarize and present results, and experience with teambased collaborations is a must
- Ability to manage an ambiguous environment and work with a sense of urgency
- Understanding of drug development and submission requirements is preferred
- Has demonstrated to be able to make decisions independently; an innovative and strategic thinker with broad vision is key for this job
- Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
- In addition to fluent English, able to read, write and speak Flemish
- Travel may be required up to 10% of time
- Eligible to work in Belgium
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