Make your mark for patients
We are looking for a
Technical Lead
who is
passionate ,
collaborative , and
results-driven
to join our
Patient Supply
team, based at our UCB campus in
Braine-l'alleud, 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 end-to-end 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 problem-solving 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 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t 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 that’s 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
EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
#J-18808-Ljbffr
We are looking for a
Technical Lead
who is
passionate ,
collaborative , and
results-driven
to join our
Patient Supply
team, based at our UCB campus in
Braine-l'alleud, 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 end-to-end 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 problem-solving 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 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t 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 that’s 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
EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
#J-18808-Ljbffr
