Senior Scientist - Drug Product Development > Joboolo BE :
Company : UCB Location : Braine-l'Alleud Wallonia From : Talent BE
You will define and select drugproduct 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 WithYou'll collaborate with a dynamic, multidisciplinary team, working closely with internal teams and external contractors to ensure the efficient development of drugproducts.What You'll DoDefine DP processes for various formulation types, providing necessary support to drugproduct 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 drugproductdevelopment 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.Interested? For this role, we are looking for the following education, experience, and skillsBachelor’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 drugproductdevelopment and/or manufacturing within the pharmaceutical industry.Good knowledge and technical experience in parenteral liquid drugproductdevelopment and cGMP manufacturing under aseptic conditions.Technical knowledge of sterile DP development, including DP components, process transfer, scale, and optimization.Understanding of phase 1 productdevelopment 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 drugproduct manufacturing process and scale-up is beneficial.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 drugproducts 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! UCB Braine-l'AlleudWallonia
