Make your mark for patients
We are looking for a Senior SME Drug Product Expert who is innovative, collaborative, and proactive to join our Pharmaceutical Development team, based at our UCB campus in Braine-l'Alleud, Belgium.
About the Role
As a Senior SME Drug Product Expert, you will lead and manage project work packages related to drug product development (formulation and process). You will ensure that our products progress from formulation orientation for First-in-Human studies to commercial registration and launch. Your contributions will significantly impact project strategies and life cycle management of our commercial brands.
Who You Will Work With
You will collaborate with experts in drug substance, drug product, and analytical functions, as well as with Drug Product Project Leads. You will also work closely with non-clinical formulation leads, QA, RA and packaging teams.
What You Will Do
1. You will lead assigned project work packages from initial studies to commercial launch.
2. You will identify optimal formulations and processes through experiments.
3. You will design, plan, perform, interpret, and report results of experiments in time to influence strategic project decisions and recommend next steps.
4. You will ensure process robustness, validation, and transfer of new chemical entities.
5. You will manage activities with external partners, being also involved in selection process.
6. You will prepare high-quality source documents including experimental plans, protocols and reports according to data integrity requirements to enable regulatory filing.
7. You will mentor and coach laboratory scientists and less experienced SMEs.
8. You will contribute to setting the sciences and technology strategy direction of the department as it relates to own area of expertise.
Interested? For this role, we are looking for the following education, experience, and skills:
9. You have 5+ years of experience in pharmaceutical development and/or manufacturing.
10. You hold a Master’s Degree or Ph.D. in a relevant field.
11. You have expertise in GMP, regulatory requirements, project management, and risk management.
12. You have excellent communication and presentation skills, able to convey complex information clearly.
13. You have a strong problem-solving mindset, designing technical experiments independently.
14. You excel at building collaborative relationships and have a proactive working style.
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!