Expert Upstream

Proclinical are recruiting for an individual to join a pharmaceutical organisation. The opening position is on a permanent basis and is located in Wallonia. The role is for an Expert Upstream (USP) Scientist.

**Responsibilities**:

- You will stay ahead on the latest quality and regulatory direction to assist with project documentation and hastened CMC proposals.
- Handle instrumental to forming mRNA platform documentation and workflows, and integration within the downstream, analytical, and any other transversal teams within the international platform.
- Responsible for has-on design and implementation of development of upstream procedures, scale-down models and process characterisation utilising DOE principles for mRNA production and tech transfer to GMP facilities on firm timelines.
- Guide internalisation of pre-established upstream mRNA vaccine platform from an external partner.
- You will serve as a representative for DS in cross-functional program teams when needed and translate project objectives into actionable plans.
- 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, engineering or a similar scientific discipline.
- At least 7 years of experience within gene therapies or mRNA-based vaccines and therapeutics.
- At least 3 years of experience in bioprocess development, ideally late-phase, as well as process technology transfer for large biomolecules using QbD principles.
- Able to resolve issues.
- Demonstrated capability in bioprocess development for the biomanufacturing of nucleic acids, ideally mRNA.
- Comprehension of general process development and analytical development actions needed for CMC assistance.
- Expertise on the large molecule regulatory setting, specifically FDA/ICH/ISPE regulations on risk management, technology transfer and process validation.
- Familiarity with nucleic acid analytical technologies.
- Fluency in both the French and English language.

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.

LI-RS2

TechOps

Scientific