We are leading the search for a Principal Scientist to join the Process Development team on behalf of our client, an established CDMO with over 50 years' expertise.
The bioconjugation scientists play a critical role in bridging the gap between small-molecule chemistry and large-molecule biologics, primarily focusing on the development and scale-up of Antibody-Drug Conjugates (ADCs) and other bioconjugates. You will execute and manage the delivery of projects supporting our clients early-stage research and then progress lead candidate into clinical-scale manufacturing, ensuring high-quality drug candidates are ready for the clinic.
- Process Design & Optimisation: Independently design and execute experiments to develop scalable bioconjugation and purification processes.
- Scale-up & Tech Transfer: Transitioning processes from bench-top research to larger-scale production while maintaining product quality.
- Downstream Processing: Optimise purification workflows using ÄKTA chromatography systems and Tangential Flow Filtration (TFF).
- Analytical Characterisation: Perform in-depth product analysis using HIC, SEC, IEX, and LC-MS to ensure quality, purity and stability.
- Data-Driven Innovation: Apply Quality by Design (QbD) and Design of Experiments (DoE) principles to identify critical process parameters.
- Collaboration: Work cross-functionally with Project Management, Process Introduction, Analytical, and Quality teams during process development and transfer into clinical manufacturing
To be successful you will hold:
- BSc/MSc/PhD in Chemistry, Biochemistry, or Chemical Biology; and with at least 10 years relevant industry experience.
- An in-depth understanding of, and proven hands-on experience with the conjugation of small molecules (cytotoxins, fluorochromes, chelators, oligonucleotides etc) to antibodies (and other proteins).
- Be skilled in all aspects of downstream process development, including reactive chemistry
- Experience working with highly potent molecules and associated containment strategies is advantageous. Knowledge of cGMP and EU, MHRA and FDA regulations
- Proficiency in interpreting complex data using software such as Chemstation, Chromeleon, ChemDraw
- Experience in high throughput / parallel process & reaction screening Process optimisation and validation for late phase / commercial