Lead Scientist - Upstream mRNA Process Development job in Rixensart, Belgium

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Job type: Permanent

Discipline: Biological Sciences

Location: Belgium

This vacancy has now expired. Please see similar roles below...

Proclinical are partnering with a pharmaceutical consultancy. This role is on a permanent basis. The opening position is for a Lead Scientist who will be mainly focusing their time and attention on Upstream mRNA Process Development.

Responsibilities:

Keep updated on the latest quality and regulatory direction to assist with project documentation and quickened CM proposals.
You will design and implement the development of upstream 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, and integration within the downstream, analytical, and any other transversal teams within the international platform.
Guide internalisation of a pre-formed upstream mRNA vaccine platform from an external partner and mature its strength, scalability, and characterisation for late phase CMC development and commercial manufacturing, overseeing more junior scientists.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to an advanced degree level in a molecular biology, biotechnology, bioengineering, chemical engineering or similar discipline.
At least 7 years of experience in gene therapies or particularly mRNA-based vaccines or therapeutics.
At least 3 years of experience working in a relevant organisation in bioprocess development, ideally late-phase, as well as process technology transfer for large biomolecules using QbD principles.
Capable of resolving issues with the ability to make sound judgements.
A background in bioprocess development for the biomanufacturing of nucleic acids, ideally mRNA.
Comprehension of general process development and analytical development actions necessary for CMC assistance.
Expertise on the large molecule regulatory setting, ideally FDA/ICH/ISPE regulations on risk management, technology transfer and process validation.
Familiarity with nucleic acid analytical technologies.

If you are having difficulty in applying or if you have any questions, please contact James Hume at +44 208 167 5468.

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.

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