Process Development Experts
EXO Biologics is a leading exosomes company aiming to develop its subsidiary Contract Development and Manufacturing Organization (CDMO) entity located in Liège, Belgium to provide integrated exosomes or extracellular vesicles development and manufacturing solutions for pharmaceutical and biotech companies worldwide.
Exo Biologics is currently hiring a Process Development Expert. The Process Development Expert main role is to lead the production process development and to participate to transfer the process in GMP cleanrooms as well as executing GMP manufacturing operations
Responsibilities
- Lead exosome production process development of the CDMO (based on in house production platform, internal subject matter experts and scientific literature)
- Become the face of the company to present exosome industrialization expertise to client, understand client’s process and propose development option with an industrial vision
- Build production process development plan
- Draft protocols, batch records and development reports.
- Assess equipment, material and people requirement to execute development plan
- Execute and support process development activities in the lab
- Execute and support GMP manufacturing operations to produce clinical material
- Follow GMP requirements
Qualifications
- At least Bioengineering degree or master’s degree in chemistry, biochemistry, biology, pharmacy, etc.
- At least two years’ experience in in mammalian cell culture
- At least one year experience in a process development or MSAT function
- Experience working in a GMP environment and writing procedures is required.
- English at least B2
Soft skills
- Customer oriented
- Good communicator, cheerful
- Teamwork and teaching skills
- Pragmatic, solution driven mindset.
- Responsible working attitude, Proactive and autonomous
- Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active
- Maintains open, effective, constructive and positive communication with colleagues in the team and in other departments.