Group Leader Downstream Process Development - London, United Kingdom - Real Staffing
Description
Group Leader (Downstream Process Development)
I am currently working alongside a global, well established Pharmaceuticals company who are branching into a range of new niches within the industry.
One of these expansions is into the Biosimilars field and as such, we are looking for a Group Leader fora Downstream Process Development for their newly re-purposed laboratories in North London.
Your purpose will be to lead downstream process development of specific biosimilar projects, conduct technology transfer, enable scale up for commercial manufacturing and process characterisation.
Responsibilities:
- Manage scientists [includes goal setting, understanding developmental needs, assigning responsibilities in the lab activities, critically assessing their performance and provide timely feedback].
- To strengthen the team to develop in depth understanding of downstream process development, consistency batches, process development using QbD approach, process capability studies, cleaning validation and resin/TFF reuse studies.
- Work in collaboration with Drug Product Development, Upstream Process Development and Analytical Development teams for completion of project goals.
- Well versed with appropriate CTD sections for regulatory submissions.
- Ensure completion of the work as per the project timelines and priorities
Technical/Experience Requirements:
- Technical competence in Downstream Process Development / appropriate scientific discipline or technology.
- Direct management experience of technical staff.
- Experience in biosimilars development would be highly desirable.
- Experience in purification of proteins from various expression hosts will be an advantage.
- Cross training in upstream process development and analytical area would be preferred
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales
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