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Senior Scientist Purification/downstream Processing
il y a 1 semaine
Eurofins CDMO is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development for chemical/biological entities and drug substance development for biologics. We support small and major biopharmaceutical companies in an innovative way to help them achieving their (pre)clinical milestones timely. Our solid track record in developing and manufacturing New Biological Entities (NBE)/New Chemical Entities (NCE) is one of our strongest asset. Our facilities are perfectly designed for small clinical and/or commercial batches either for sterile or non-sterile dosage forms. With approximatively 400 staff, we operate out of 10 sites either in France or Belgium.
Job Description:
Cell culture and fermentation are the starting points in the production of therapeutic proteins for our clients.
In a following step the target proteins are
purified to obtain a bulk drug substance (DS) which fulfils set specifications.
As a Senior scientist your main responsibilities will be in
developing and performing manufacturing processes for biologics, starting from harvested material from microbial or mammalian cells, taking into account the regulatory requirements and clients' needs.
In this role you will define the most optimal purification process (chromatography, filtration, sample treatment steps) in function of the protein characteristics, upscale the downstream process and (if required) assure a smooth transfer to the GMP production site.
Your main responsibilities are:
- As a senior scientist and being a member of the Downstream Processing group, you will be assigned to act as a lead scientist for one or more specific projects. This means review of scientific work, setting up and rework of experimental plans based on gathered results from project team and followup of all downstream related activities. You will carry end responsibility towards the quality of output, results, reports and methods
- As senior scientist, you will be responsible over time for guiding one or multiple people in function of his/her assigned projects and act as a scientific mentor
- Develop purification processes for biologics, such as cell homogenisation, fractionation, chromatography, normal flow filtration, tangential flow filtration
- Perform scaleup studies
- Participate in the transfer of the purification process to the GMP facility
- Writing/updating or reviewing Standard Operation Procedures, Batch Record Documents and reports
- Participate in production runs performed in development and GMP environments in accordance with the applicable requirements as described in procedures
- Follow the applicable quality system, identify and report all deviations and/or unexpected events, and support corrective and preventive actions
- Communicate the status of operations to the Team Leader, Project Leader and the client
- Followup new technologies in the field and support strategic decisions concerning future investments
- Maintain a clean and safe work environment
Qualifications:
- A PhD Degree in Life Sciences with relevant experience (production of proteins)
- You have a proven, hands on experience with protein chemistry, purification processes and the operation of Akta and/or Bioprocess equipment
- You are keen on being present in a laboratory/production environment
- Knowledge of GMP and current guidelines by regulatory instances is a plus
- You are accurate and you have a strong eye for detail
- You're creative and a problemsolver
- You can work independently and you have excellent organization skills
- You're a team player and have good communication skills
- You're able to work a flexible schedule
- Fluent in English (written and spoken).
- Work in a fast growing organization.
- A position with responsibility within a dynamic company.
- Personal development through learning on the job and additional external trainings.
- A market oriented compensation.
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