Analytical Development Physical Chemical Protein Analysis Supervisor
Analytical Development Physical Chemical Protein Analysis Supervisor
DEMO Pharmaceuticals
Athens, Greece
Main duties and responsibilities:
- Conduct protein analysis with emphasis of their physical and chemical properties, e.g protein impurities evaluation, glycosylation, molecular mass, amino acid composition etc.;
- Analytical methods development and qualification;
- Data interpretation and reports writing;
- Trouble shooting;
- Regulatory documentation editing;
- Support of Process development by providing the analytical data;
- Analytical methods transfer to QC;
- Contribute to development projects by:
- Follow and implement EU and US regulations regarding all aspects related to the quality and analytical characterisation of biological medicinal products with an emphasis on biosimilars development;
- Setup and maintenance of the analytical infrastructure required for AD with emphasis to physical and chemical properties laboratories;
- Collaboration with Quality Assurance dept. to set up and supervision the quality system required to run Analytical Development and QC depts.
- Facilitate internal trainings to Bio-team colleagues.
Requirements
- Bachelor’s Degree in Biology, Biotechnology, Chemistry or related with post graduate studies (MSc/PhD) in a field related to biotechnology, biochemistry or molecular biology;
- Minimum 6 years of experience in biotech or pharmaceutical company in the field of biotech;
- Good understanding of regulations required for analytical development of biotech products, preferably in biosimilars development;
- Working experience in method development and validation of common pharmaceutical analytical techniques such as: HPLC, UPLC, FTIR, CD, Capillary Electrophoresis;
- Very good knowledge of software like: Empower, Data visualization and statistics like: Graph Pad Prism, JASP, JMP or similar;
- Knowledge of regulations required for analytical development of biotech products, preferably in biosimilars development;
- Strong problem solving attitude, critical thinking;
- Resilience & ability to work independently;
- Excellent communication skills both verbal and written;
- Team player & fast learner.
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