Downstream Process Development Science Manager
2 months ago
This is an exciting opportunity to join a market leading developer of albumin-enabled solutions for advanced therapies and next generation biopharmaceuticals as a Downstream Process Development Science Manager, within the Technical Support Group, to managedownstream technical support activities for biopharmaceutical manufacturing and to generate recombinant protein-based products at laboratory scale.
The role will be based in the newly renovated and modern offices located in Nottingham.
**Main Responsibilities**
- Ensure that manufacturing processes operate in compliance with cGMP
- People management of Downstream Process Development team members
- Manage technical support for biopharmaceutical manufacturing with expert analysis of downstream process steps and assay methods
- Identification of process optimization activities, perform scale down studies at bench scale, and management of their implementation at large scale.
- Develop and test processes ready for technology transfer to manufacturing. Support technology transfer projects for cGMP manufacturing to other sites.
- Investigation and recommendation of new technologies for use in downstream processes.
- Perform and/or direct formal investigations of non-routine events or deviations raised through Quality systems. Report writing, identification and implementation of appropriate corrective actions.
- Perform and/or direct the trending and review of batch process data and contribute to continued process verification.
- Identification of process optimisation activities, perform scale down studies at bench scale, and management of their implementation at large scale.
- Investigation and recommendation of new technologies for use in downstream processes.
- Provide downstream processing support to generate recombinant protein-based products for internal/external projects.
**Requirements**:
- Minimum of a Bachelor's Degree level education in a Life Sciences field, biochemical/chemical engineering or related discipline, with relevant purification/analytical industrial experience.
- Preferably, either a PhD with at least 5 years' experience, or MSc with at least 8 years' experience or BSc with at least 12 years' experience in a purification/analytical assay industry
- Experience working with AKTA chromatography systems is desirable
- People management experience is desirable
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