MSAT Specialist USP – Level III
An exciting opportunity working as a Senior USP MSAT has become available working with a global biotech company based in the Nordics
- To be responsible for writing Scale-up strategy prior to tech transfer of manufacturing processes to GMP Manufacturing across clinical and commercial to both internal and external manufacturing sites if needed.
- To be accountable for the introduction and support of qualification of new processes into cGMP manufacturing, whilst managing technical risks associated with process transfer, leading cross functional teams to ensure relevant transfer and communication of critical process and technical information such that successful outcomes are achieved as agreed.
- Investigate, identify root cause, and identify CAPA for manufacturing deviations.
- To be accountable for independent on plant technical support, process monitoring and complex data analysis using experience to anticipate issues before they become critical.
- To represent MSAT within multiple complex external/internal project teams and pro-actively communicate, effectively negotiate, collaborate via both face to face meeting and telecoms driving problem resolution and offer successful technical outcomes
- To lead process optimization/ improvement activities leading cross functional teams to successfully implement according business needs.
- To use technical influence and knowledge in project teams to ensure delivery of project timelines according to business needs.
- To proactively anticipate, evaluate and resolve technical challenges within area of expertise
- To be self-managed in resolving gaps in unit operations through batch reviews and applied continual process learning/knowledge capture.
- To be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
- To coach and mentor new starters to contribute to achieving a multi-skilled and engaged USP team.
- Adhere to the company etiquette in all matters of behaviour and manners.
- To be able to work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision.
EDUCATION AND EXPERIENCE
MSc degree in Biological science or biochemical engineering disciplines or equivalent means of demonstrating ability with significant experience in industry or a relevant academic environment
- Experience of cell culture principles, techniques, scale up, technology transfer and process validation activities.
- Strong knowledge in laboratory development and/or a manufacturing operations background.
- Be a recognized expert in field USP drug substance operations from working in a cGMP environment.
- A minimum of 5 years technical transfer expertise gained from a drug substance manufacturing environment.
- Have demonstrable experience working in cross functional project management and technical transfer activities with ability to multitask, prioritize and be an effective decision maker.
- Have a deep understanding of manufacturing process as a whole e.g. Supply chain, analytical, QA.