Process Science Lead (monoclonal antibody)
A leading and global biopharmaceutical company is currently hiring a Process Science Lead to join their team. This is an exciting opportunity to bring expertise and skills to an established and in-demand company which specialises in precision medicine for neurodegenerative diseases.
- Responsible for the development of cell culture (Upstream - USP) and purification (downstream - DSP) manufacturing processes for the company Monoclonal Antibodies pipeline.
- Providing technical guidance and direction to rapidly moving Antibodies into clinical stage.
- Direct studies to define optimal USP/DSP process development aimed at delivering highly productive / high quality processes.
- Working in collaboration with the selected CMO to designs robust and scalable USP/DSP processes using scientific and engineering concepts.
- Working in close collaboration with the Antibody engineering team, with cell line development, analytical & formulations development and strive for CMC team success.
- Evaluating/interpreting data and communicate results to management and the CMC team as required
- Contributing to the introduction of scientifically/quality driven approaches such as QbD or DoE (Design of Experiments).
- Ensuring product supply from the Research grade materials to the Tox batches.
- Interact directly with the selected CMO for planning and tasks execution.
- Ensuring transition of Research manufacturing processes into Development.
- Establishing solid scientific approach in the development of DS manufacturing processes.
- Define USP and DSP process development roadmap in collaboration with the CMO.
- Developing suitable and scalable DS manufacturing process(es).
- Identifying and manage allocated budget and resources requirements.
- Taking responsibility for production and supply of Research grade material
- Be responsible for production and supply of Tox material.
Skills and Requirements:
- Doctorate (Ph.D.) degree in cell biology, chemical engineering, bioengineering, or a related field.
- At least 10 years of experience, preferably in early stage Product Development.
- Expertise in cell culture process development and scale up.
- Hands on experience with protein purification.
- Must be forward-thinking and be able to lead and contribute to scientific/technical discussions.
- Strong communication skills including verbal, written, and scientific data presentation.
- Good understanding of biochemistry and bioprocess engineering concepts.
- Strategic thinking and working collaboratively within and outside of the group.
- Demonstrated effective leadership in industrial setting is preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Patrick Franke at +44 02074400632 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.