The Senior Specialist MS&T (DS Process Science) delivers a range of technical support to the Drug Substance Business: supporting technical investigations within the Integrated Process Team, supporting significant projects in the MS&T laboratory, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.

Duties and Responsibilities:

• Leading, designing, supporting and executing experimental design, data analysis and interpretation to resolve complex deviations.
• Leading process improvement and troubleshooting with end-to-end product focus. Assist in, and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.
• Executing experimental design, data analysis and interpretation
• Supporting the process sciences team during small scale model run execution, including buffer preparation, equipment set up, run execution, sampling and data analysis.
• Author and review standard operating procedures (SOPs), protocols and reports as required.
• Support continuous improvement through Lean Six Sigma methodologies.
• Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

• A Master’s degree in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering with 2+ years’ experience or a Bachelor’s degree in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering with 4+ years’ experience.
• Experience leading technical related projects.

• Demonstrated leadership and proven track record of delivering projects of technical complexity
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Desirable evidence of continuous professional development.
• Experience in drug substance process development, process characterisation studies, downstream technology, and/or process modeling.
• Experience in designing and executing experimental programs in the laboratory. Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Technical experience in the drug substance manufacture of biological molecules at the lab, pilot and/or commercial-scale.
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical writing skills.
• Demonstrated leadership and change management skills with a continuous improvement focus
• Proven track record of delivering high performance through development and coaching of a team.
• Evidence of continuous professional development.
• Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
• Desire to continuously learn, improve and develop.