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Head of gene therapy drug substance process development

Braine-l'Alleud
Ucb Pharma
Publiée le Publiée il y a 22 h
Description de l'offre

Make your mark for patients

We are looking for a Head of Gene Therapy Drug Substance Process Development who is visionary, collaborative and a nurturing leader to join our Drug Substance Process Sciences (DSPS) team, based at our UCB campus located in Braine‑l'Alleud, Walloon Brabant, Belgium.

About the role

You will organize, manage and lead UCB's AAV drug substance process development capabilities from first‑in‑human through BLA and lifecycle and contribute to drug substance development across modalities. You're going to set strategy, establish advanced technologies, and select the right internal and external partners to deliver with urgency. You will pioneer sustainable, innovative CMC solutions across modalities, ensure regulatory readiness, and embed quality and HSE excellence. You will recruit, coach, inspire and develop a diverse team of scientists and engineers within and outside of your team, shaping best‑in‑class processes, technologies and platforms that advance patient care and reinforce UCB's leadership in drug substance development.

Who you will work with

You will collaborate closely with DSPS leadership, drug substance project management, clinical manufacturing, Patient Solutions, process engineering, drug product, analytical sciences, quality, regulatory, procurement, alliance management, and HSE. You're going to build strong partnerships with CDMOs, suppliers, and academic groups across countries. You will act as a change agent, harmonizing approaches across biologics, advanced therapeutic products, and synthetic molecules, while engaging regulators and key opinion leaders.

What you will do

1. You will build and lead AAV drug substance process development from first‑in‑human to BLA submission and lifecycle.
2. You will define strategy, technology roadmaps, and partnerships across internal teams, CDMOs, suppliers, and academia.
3. You will manage, coach, and grow a diverse team of scientists and engineers; foster learning, inclusion, and performance.
4. You are going to drive scale‑up, tech transfer, control strategies, and investigations for AAV processes at internal and external sites.
5. You will contribute to drug substance development across modalities.
6. You will ensure regulatory readiness: CMC deliverables, data integrity, HSE compliance, QbD/DOE studies, filings, inspections support.

Interested?

You will pioneer sustainable, innovative CMC solutions that accelerate therapies and strengthen UCB's leadership in gene therapy.

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

7. Ph.D. in life sciences or engineering; 10+ years' CMC development experience in biopharmaceuticals.
8. Proven people and change leadership in complex matrices; hiring, mentoring, and performance management.
9. Deep biotechnology process sciences expertise; publications, patents, and conference presence.
10. Strong regulatory knowledge; authored IND/BLA CMC sections and responses; engages authorities confidently.
11. Hands‑on with QbD, DOE, scale‑up, bioreactors, characterization, validation, and tech transfers.
12. Excellent collaboration, communication, and business acumen; influence regulators and key opinion leaders.

#genetherapy

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 over 9.000 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 equal 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.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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