- Define DP processes for various formulation types, providing necessary support to drug product process development activities.
- Ensure timely delivery of stability and clinical DP batches, and support validation of commercial DP processes for late-stage projects.
- Prepare protocols and reports, execute studies related to drug product development activities.
- Ensure critical process data capture and appropriate analysis of processes.
- Assist in completing relevant sections of CMC regulatory submissions.
- Support the definition of IMP preparation process in clinical trials and investigations of deviations and complaints related to DP quality.
- Ensure efficient knowledge transfer from late-phase development to LCM for validated DP processes.
- Bachelor's or Master's degree in a relevant scientific field (e.g. pharmaceutical sciences, biotechnology, bio or chemical engineering)
- Minimum of 3 years of experience in sterile drug product development and/or manufacturing within the pharmaceutical industry.
- Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions.
- Technical knowledge of sterile DP development, including DP components, process transfer, scale, and optimization.
- Understanding of phase 1 product development issues and challenges is advantageous.
- Knowledge of primary packaging and regulatory requirements is a plus.
- Knowledge of analytical, preformulation, and formulation development is advantageous.
- Understanding of biologicals drug product manufacturing process and scale-up is beneficial.
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Senior Scientist - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
We are seeking a Senior Scientist - Drug Product Development who is passionate about innovation, results-oriented, and possesses excellent communication skills to join our Biological Characterisation and Pharmaceutical Development Sciences (BCPDS)team, based in Braine l'Alleud , Belgium.
About the Role
As a Senior Scientist - Drug Product Development, you will be responsible for establishing robust, fit-for-purpose manufacturing processes for biological drug products across different development phases (Ph1, Ph2, Ph3). You will define and select drug product manufacturing processes and parameters for clinical manufacturing and build close collaboration with the External DP Clinical Manufacturing Team. Additionally, you'll support the development and implementation of systems and processes for the DP CMC development strategy within BCPDS.
Who You'll Work With
You'll collaborate with a dynamic, multidisciplinary team, working closely with internal teams and external contractors to ensure the efficient development of drug products.
What You'll Do
Interested? For this role, we are looking for the following education, experience, and skills
We're seeking a candidate with excellent communication, negotiation, and team player skills. Being autonomous with good problem-solving skills and efficient prioritization abilities are essential.
Join our dynamic team and contribute to shaping the future of biological drug products with us
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
