Biological Characterization Project Lead

Description:

You will join a team of 60 experienced scientists responsible for the comprehensive characterisation of proteins using advanced techniques such as mass spectrometry, AUC, and higher-order methods. Your work will help elucidate protein structure, function, degradation pathways, and support critical quality attribute (CQA) assessment and control strategies. This role is not lab-based and focuses on supporting early-phase projects as they prepare for INDs, requiring both technical expertise and strong project management skills.

You will collaborate with colleagues in characterisation, formulation, analytical method development, upstream and downstream science, devices, quality control, stability, statistics, regulatory, and quality assurance. You’ll also interact with teams across the UK, Belgium, Switzerland, the US, contract labs, and academic partners. The environment is dynamic, with multiple parallel activities and changing priorities, so adaptability and minimal supervision are essential.

Who You’ll Work With

You will work closely with scientists across CMS, formulation, analytical, and regulatory teams, as well as with external contract labs and academic collaborators. You’ll present data and insights to project teams and management, ensuring alignment and quality throughout the project lifecycle.

What You’ll Do
 

• Represent early-stage projects both technically and as a project manager
• Input into the design of characterisation work packages
• Contribute to critical quality attribute (CQA) assessments
• Author and review analytical aspects of regulatory submissions, protocols, and reports
• Liaise with scientists to obtain and interpret data
• Communicate issues and findings to principal scientists and management
• Manage documentation, including risk assessments and quality management system activities
• Ensure quality processes are maintained and followed
• Engage in self-learning by reviewing relevant scientific literature
   

Interested? For this role, you’ll need:
 

• Bachelor’s degree required; Master’s or PhD preferred
• At least 5–10 years of industrial experience in biotechnology or pharmaceutical characterisation, with sustained project representation experience
• Excellent knowledge of protein chemistry
• Proficiency in electronic document management systems, quality management systems, and risk databases
• Experience working with internal regulatory teams and responding to regulatory agency submissions