Technical Lead 89261
Technical Lead 89261
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Job Description
Make your mark for patients
We are looking for aTechnical Leadwho ispassionatecollaborativeand resultsdrivento join ourPatient Supplyteam based at our UCB campus inBrainelalleud Belgium or Slough UK.
About the Role
As a Technical Lead you will define implement and manage the Product Chemistry Manufacturing and Controls (CMC) development strategy for New Biological Entity (NBE) candidates ensuring their successful transition from research to development with commercialization in mind.
Who You Will Work With
You will collaborate with the Candidate Development Team and the Patient Supply organization overseeing all aspects of technical development driving patient value through translation of business and patient requirements into sustainable technical solutions.
What You Will Do
- Provide CMC leadership oversight for NBE development candidates during early development in alignment with Quality by Design principles.
- Act as the Patient Supply representative in the Candidate Team ensuring technical aspects are appropriately considered in the candidate development strategy.
- Lead the Technical Solutions Team (TST) to define and implement optimal CMC development strategies aligned with the candidate development plan Target Product Profile (TPVP) and Quality Target Product Profile (QTPP).
- Develop and drive the CMC development plan ensuring alignment with overall program goals.
- Contribute to the candidate budget definition and management by consolidating and tracking CMC activities resources and budget.
- Ensure the availability of phase appropriate documentation and submission readiness for regulatory approvals.
Communicate key updates and decisions from/to stakeholders and governance committees..
Interested For this role we are looking for the following education experience and skills:
- At least 5 years experience in CMC development for biological (preferred) and/ or pharma products.
- Comprehensive understanding of the endtoend CMC development process and its major steps.
- Extensive experience across various stages and disciplines of CMC development. Proven leadership experience within a matrix management environment.
- Strong project leadership skills with a focus on decision making.
- Ability to think holistically and demonstrate strong accountability with a proactive problemsolving mindset.
Excellent communication and collaboration skills to foster teamwork.
Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!
About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equitable opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Employment Type
Contract
