External Clinical Manufacturing Lead

As an External Clinical Manufacturing Lead, you will support the definition and implementation of the external Drug Substance (DS) & Drug Product (DP) clinical manufacturing strategy for New Chemical Entity (NCE) drug substances and drug products. You will lead the knowledge and technology transfer of manufacturing processes to external Contract Manufacturing Organizations (CMOs) and oversee clinical manufacturing activities to ensure successful batch production. Who you will work with You will collaborate closely with line management, Subject Matter Experts (SMEs), project teams, Technical Solutions Teams, External Manufacturing Operations, Clinical Supply Teams, Quality Assurance, and other stakeholders to ensure seamless project execution. What You Will Do

• Lead the knowledge and technology transfer of manufacturing processes to external CMOs.
• Oversee clinical manufacturing activities at CMOs and ensure successful batch production.
• Manage issues, deviations, and investigations with support from development teams.
• Act as the first point of contact for technical aspects of clinical manufacture.
• Author necessary documentation for knowledge and technology transfer.
• Manage deviations, investigations, and change controls related to process transfer activities., 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!
  
  Minimum 5 years of experience in New Chemical Entity (NCE)/New Biological Entity (NBE) drug development and/or manufacturing.
• Knowledge of NCE Active Pharmaceutical Ingredient (API) and DP manufacture/development for oral dosage forms.
• Good understanding of cGMP and regulatory requirements.
• Excellent communication, negotiation, and team player skills.
• Experience in managing process change controls and deviation investigations.
  
  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.