Job Description

Make your mark for patientsWe are looking for an External Clinical Manufacturing Lead who is proactive, collaborative, and results-oriented to join our Manufacturing Operations team, based at our UCB campus in Braine-l'Alleud, Belgium.About the RoleYou will define and implement the overall external clinical manufacturing strategy for drug substances and drug products through various stages of development. You will be the primary point of contact for all technical aspects of clinical manufacturing and knowledge/technology transfer with external CMOs.Who You Will Work WithYou will collaborate closely with Technical Solutions Teams, External Manufacturing Operations, Clinical Supply Teams, Quality Assurance, and other project stakeholders. You will be supported by Development teams in managing issues, deviations, and investigations.What You Will Do

• You will define and implement the overall external clinical manufacturing strategy.
• You will be responsible for the knowledge/technology transfer of manufacturing processes to external CMOs.
• You will manage clinical and stability batch manufacturing, ensuring on-time delivery.
• You will author and approve necessary documentation for knowledge transfer and clinical batch manufacturing.
• You will manage deviations and lead investigations and change controls related to transfer activities.
• You will coordinate the shipping of drug substances and products with Supply Leads.

Interested?For this role, we are looking for the following education, experience, and skills:

• Bachelor's Degree or Master's Degree in pharmaceutical sciences or a related field.
• Minimum 5 years of experience in NCE/NBE drug development and/or manufacturing.
• Knowledge of NBE drug substance manufacturing/development and injectable dosage form manufacturing/development.
• Good knowledge of cGMP and regulatory requirements.
• Excellent communication, negotiation, and teamwork skills.
• Knowledge of analytical, preformulation, and formulation development is an advantage.

Are you ready to xe2x80x98go beyondxe2x80x99 to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About usUCB 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 donxe2x80x99t just complete tasks, we create value. We arenxe2x80x99t 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 xe2x80x98go beyondxe2x80x99 to create value for our patients, and always with a human focus, whether thatxe2x80x99s 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.

UCB