Analytical Development Bioassay Senior Scientist

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DEMO Pharmaceuticals

Develop and qualify methods for the characterization and quantification of biosimilar products, including potency, cell-based assays, DNA content, ELISA and SPR;
Design experimental protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing;
Analyse data, interpret results, and provide scientific insights to guide decision-making in collaboration with cross-functional teams;
Stay current with developments in advance 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 mass spectrometry and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.

MSc in Biology, Biotechnology, Biochemistry or related field;
PhD in a field related to Biology, Biotechnology, Biochemistry, Molecular Biology is considered an asset;
Industry experience in monoclonal antibodies. Experience in biosimilars is considered an asset;
Strong expertise in analytical techniques for protein analysis regarding their biological properties e.g. ELISA, Molecular biology techniques, cell-based assays, SPR, Q-PCR etc with a focus on protein characterization and analysis;
Demonstrated ability to design and execute complex experiments, analyze data, and communicate results effectively to diverse stakeholders;
Familiarity with regulatory requirements for biopharmaceutical characterization, including ICH guidelines, FDA/EMA regulations, and industry standards;
Excellent written and verbal communication skills, with the ability to collaborate effectively in a cross-functional team environment;
Strong problem-solving abilities and attention to detail, with a commitment to delivering high-quality results on time and within budget;
Software knowledge like: excel, Data visualisation and statistics like: Graph Pad Prism, JASP, JMP or similar;
Experience in quality system – GMP, GLP or Good Development Practices will be advantage;
Excellent communication skills both verbal and written in English;
Strong problem-solving attitude, critical thinking;
Resilience & ability to work independently.