Principal Scientist

Principal Scientist

Lonza

Slough, United Kingdom

We are looking for an experienced Principal Scientist to lead the Technical Transfer of complex manufacturing processes (primarily DSP) using a structured approach from Process Development, through pilot stage to implement a robust and technically capable cGMP manufacturing process suitable for commercial registration. You will lead, advise and direct project outcomes with a strong ability to anticipate and resolve technical challenges through leading internal cross functional teams.

The role is open for international applications with visa and relocation support.

What you will do:

• As an influential MSAT representative within multiple customer product project teams, lead the successful transfer both defined as well as new complex process stages either into USP or in DSP operations supporting development through to oversight of all cGMP commercial manufacturing stages - using a standard methodology/procedure;
• Be accountable for the introduction and support of qualification of new process technologies into cGMP manufacturing, whilst managing technical risks associated with process transfer, leading cross functional te;ams to ensure relevant transfer and communication of critical process and technical information such that successful outcomes are achieved as agreed with customer
• You will be responsible for delivering effective operator training for critical unit/process operations and off line support of quality actions (e.g. deviations, change controls, CAPA’s);
• Independent 24/7 on plant technical support, process monitoring and complex data analysis using experience to anticipate issues before they become critical;
• Contribute to the immediate resolution of identified complex manufacturing process issues through use of knowledge and experience, leading RCA procedures to ensure continuous improvements are made to the cGMP manufacturing processes and operations;
• Proactively anticipates, evaluates and resolves technical challenges within area of expertise and is self-managed in resolving gaps in unit operations through batch reviews and applied continual process learning/knowledge capture. Is aware of external biopharmaceutical manufacturing technology advancements, understands and introduces new technologies and how they may be applicable to process innovation, cost or yield improvement.

What we are looking for:

• PhD degree in purification development or equivalent experience;
• Have in depth knowledge in field of expertise gained either from laboratory development or manufacturing operations back ground working as an individual contributor and as a strong team player in a technical process transfer capacity;
• Be a recognized site SME in field of relevance e.g. USP or DSP operations from working in a cGMP environment;
• Strong interpersonal skills;
• Customer facing experience;
• Experience of cross functional Project Management Proven with an ability to multi task, prioritize and make effective technical decisions;
• Be solution focused with a track record of implementing process improvements and excellent technical attention to detail, communication skills both written and verbal, interpersonal qualities with a continuous improvement positive mind set.