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External clinical manufacturing operations lead

Braine-l'Alleud
Ucb Pharma
Publiée le 2 avril
Description de l'offre

Make your mark for patients


We are looking for an External Clinical Manufacturing Lead who is collaborative, technically curious, and delivery‑focused to join our Clinical Manufacturing team, based at our UCB campus located in Braine‑l’Alleud, Walloon Brabant, Belgium.

About the role

You will play a key role in shaping and executing the external clinical manufacturing strategy for drug substance and drug product. You will work across development stages, ensuring successful technology transfer and reliable clinical batch manufacturing through our global CMO network. You will be at the center of technical decision‑making, issue resolution, and cross‑functional collaboration, helping to bring innovative medicines from development to clinical supply.

Who you will work with

You will work closely with CMC project teams, DS/DP sub‑teams, External Manufacturing Operations, Clinical Supply, Quality Assurance, and regulatory stakeholders. You will also collaborate daily with external CMOs, acting as a trusted technical partner and first point of contact for clinical manufacturing and technology transfer activities.

What you will do

1. You will define and implement external clinical manufacturing strategies across development stages.
2. You will lead knowledge and technology transfer to external CMOs.
3. You will oversee clinical and stability batch manufacturing, ensuring on‑time delivery.
4. You will manage deviations, investigations, and change controls with internal SMEs.
5. You will coordinate batch planning, scheduling, and DS/DP logistics with Supply Leads.
6. You will provide technical troubleshooting and manufacturing status updates to project teams.

Interested?

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

7. You will hold a Master’s degree in science, engineering, or a related field.
8. You will bring at least 5 years’ experience in NCE/NBE development or manufacturing.
9. You will demonstrate strong knowledge of DS/DP manufacturing and technology transfer.
10. You will apply solid understanding of cGMP and regulatory requirements.
11. You will communicate clearly and collaborate effectively with internal and external partners.
12. You will be comfortable managing complexity across global, cross‑functional environments.


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!

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