Expert Scientist, Downstream - mRNA Drug Substance
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Proclinical are collaborating with a pharmaceutical organisation who are currently looking for an individual to join their team. This role is on a permanent basis. The opening position is for a Scientist, Downstream.
- Serve as a representative for DS in cross-functional program teams when necessary as well as translate project objectives into actionable plans.
- Guide internalisation of a pre-established downstream mRNA vaccine platform from an external partner, as well as mature its sturdiness, scalability, and characterisation for late phase CMC development and commercial manufacturing, monitoring more junior scientists.
- Be in front of the latest quality and regulatory leadership to assist with project documentation and quickened CMC proposals.
- You will design and implement the development of purification procedures, scale-down models and process characterisation utilising DOE principles for mRNA manufacturing and tech transfer to GMP facilities on firm timelines.
- The ideal candidate will be instrumental to forming mRNA platform documentation and workflows, as well as integration within the upstream, analytical, and any other transversal teams within the international platform.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to an advanced degree level within molecular biology, biotechnology, bioengineering, chemical engineering, or a similar scientific discipline.
- Demonstrated experience within chromatography and any other purification practices, for example: tangential flow filtration (TFF) and related instrumentation, for example: AKTA chromatography systems and Unicorn software.
- Exhibited experience within the industry handling bioprocess development (ideally at late-phase) and process technology transfer for large biomolecules using QbD principles.
- Able to resolve issues by thinking critically.
- Familiarity with preparative reverse phase HPLC (RP-HPLC).
If you are having difficulty in applying or if you have any questions, please Patrick Turbidy on +44 203 530 5120.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.