External Clinical Manufacturing Lead

UCB S.A.; Slough; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global biopharmaceutical company is seeking an External Clinical Manufacturing Lead to define and implement the external clinical manufacturing strategy. This role involves collaboration with various teams and managing technical aspects of clinical manufacturing. Candidates should have a degree in pharmaceutical sciences and significant experience in drug development.

Qualifications

• 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.

Responsibilities

• Define and implement the overall external clinical manufacturing strategy.
• Manage clinical and stability batch manufacturing, ensuring on-time delivery.
• Coordinate the shipping of drug substances and products with Supply Leads.

Skills

Communication

Negotiation

Teamwork

Education

Bachelor's Degree in pharmaceutical sciences

Master's Degree in pharmaceutical sciences

Job description

Make your mark for patients

We are looking for anExternalClinical Manufacturing Leadwho isproactive, collaborative, and results-orientedto join ourManufacturing Operationsteam, based at our UCB campus inBraine-l'Alleud, Belgium.

About the Role

You 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 With

You 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 DegreeorMaster's Degreein 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 ‘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 [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.