Senior Scientist Purification/downstream Processing
il y a 4 semaines
Company Description**
Eurofins Scientific** is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 55,000 staff across a network of more than 1000 independent companies in over 50 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
**Eurofins CDMO **is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).
Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs.
**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 biologicals**, 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 follow-up 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 scale-up 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
- Follow-up 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 problem-solver
- You can work independently and you ha
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