Gene Therapy Technical Lead

工作内容

To strengthen our Supply and Technology Solutions (S&TS), based in Braine, Belgium we are looking for a talented individual to fill the position of: Technical Lead in Gene Therapy.

As a Gene Therapy Technical Lead, you will identify and foster purposeful partnerships with key scientific influencers to drive new sources of patient value.

You like to work in an environment where, for the technical development aspects of the assigned GT product(s)

• You have the overall responsibility for defining, implementing and managing the technical development strategy (S&TS: CMC/device) for GT assets as they progress from research into early development.
• You are the interface between S&TS and the GT Project Team (Research Team during pre-candidate stages of the asset and Development Team, Patient Value Mission, post candidate stages).
• You lead the translation of business requirements into technical solutions and ensure technical aspects translate into meaningful business impact.

You will contribute by:

• Leading the GT Technical Solution Team(s) (TST) ensuring appropriate teamwork and communication with all members of the Technical Team across functions (Quality, Regulatory, CMC, Device, Supply). Together with the Technical Team, you will define the technical development strategy (CMC/device) of the assigned GT product(s). You will work with the Technical Team on scenarios, assessing technical feasibility and select the optimal technical development strategy to move the GT candidate(s) seamlessly from research into early development, keeping the end goal in mind and considering late stage development and commercial.
• Representing the GT TST (CMC/Device) in the GT Project Team (Research and Patient Value Mission). You will work in close collaboration with the GT Project Team (Research and PV Mission) and contribute to the definition of the target product profile for the assigned GT product, working with Preclinical and Clinical to have all technical development aspects appropriately considered when defining the asset development strategy. You will ensure appropriate communication with key stakeholders including with the GT Project Team in place (Research or PV Mission) and relevant governance bodies.
• Building the GT TST (CMC/Device) development strategy, aligned with the GT Project Team and driving the GT TST accordingly from strategy definition into the implementation, tracking and reporting ongoing performance of TST activities against agreed objectives, milestones and budget.
• Contributing to the GT product 10 Year Plan and Yearly budget by defining and consolidating related TST activities, resources and budget.
• Leading pro-actively the GT TST risk analysis and ensuring appropriate mitigation plans are implemented and properly reported to the S&TS risk committee.
• Driving the application of Quality by Design principles in the GT TST development plans, initiating with the GT TST the work on the QTPP (Quality Target Product Profile) for the assigned GT product(s).
• Driving the GT TST to support submission file readiness for CTA and subsequent license applications.
• Contributing to the Technical Development/ Technical Lead community by driving or participating in improvement initiatives to ensure best in class CMC project management.

Interested? For this position you’ll need the following education, experience and skills:

• At least 5 years’ experience in technical development (CMC/device) in NBE and/or GT.
• Solid understanding of the end-to-end technical development process and its major steps.
• Significant background across different stages and disciplines of technical development, including deep expertise in at least one CMC development discipline and professional experience across at least two different stages of CMC development.
• At least 5 years’ experience with project management tools, including project planning, monitoring and timely reporting.
• Proven leadership skills, including ability to guide the entire GT Technical Team, issue resolution, listen and drive decisions. You will welcome all inputs, challenge each Team member and build and integrated Team Identity.
• Ability to lead by influence highly expert Technical Team members in a transversal management setting across departments (QA, RA, Supply, CMC, Device).
• Ability to bridge between sparring partner to expert scientists and enabler of senior management decision making.
• Ability to identify and address potential problems / areas for improvement pro-actively and act on them in a problem-solving manner.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.