Analytical Development Physical Chemical Properties Protein Analysis Scientist
DEMO Pharmaceuticals
Athens, Greece
Main duties and responsibilities
- Working with a team of scientists to conduct experiments in support of biosimilar development programs;
- Perform routine sample analysis on spectrometric methods, UPLC/HPLC and CE to support the process development and optimization;
- Develop and qualify spectrometric methods, UPLC/HPLC and CE methods for the characterization and quantification of biosimilar products, including peptide mapping, DLC, DSC, SEC and IEX;
- Execute protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing;
- Stay current with developments in new technology and industry best practices, incorporating new methodologies and techniques as appropriate;
- Contribute to regulatory submissions by preparing technical documents, assay validation reports, and other supporting documentation in compliance with regulatory guidelines;
- Perform method qualification, optimization, and troubleshooting to ensure robustness, accuracy, and precision of analytical assays;
- Interpret data and collaborate with bioanalytical and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.
Requirements
- B.Sc. or M.S. in Analytical Chemistry, Biochemistry, or related field with 1+ years of industry experience in UPLC/HPLC and CE techniques, preferably in a biopharmaceutical or biosimilar development setting;
- Knowhow in spectrometric methods, UPLC/HPLC and CE techniques;
- Strong problem-solving abilities and attention to detail, with a commitment to delivering high-quality results on time and within budget;
- Understanding of protein chemistry, biophysical characterization techniques;
- Excellent communication skills;
- Experience in quality systems – GMP, GLP or Good Development Practices will be an advantage;
- Critical thinking & problem solving;
- Resilience and ability to work independently;
- Good communication and team player;
- Fast learner.
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