- Work under the guidance of a supervisor with high degree of independence.
- Responsible for the development of robust and reliable ligand binding and /or cell-based assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various biological matrices using a range of potential screening platforms and assay techniques.
- High degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.
- Laboratory focused position to design, develop and implement ligand binding assays (e.g. ELISA, ECL detection) in biological matrix (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity utilizing various platforma in a regulated (GLP, GCP) environment against challenging time lines.
- When needed, participate in the design, development and implementation of cell-based assays.
- (optional) Design, develop and/or implement PCR assays in biological matrix (solid tissues, biofluid) to measure RNA and DNA molecular copies in a regulated (GLP, GCP) environment.
- Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
- Gathers input from colleagues, literature, and additional resources to assist in driving the project forward.
- Timely delivery of concentration and immunogenicity data to a supervisor and other partners in compliance with local or global regulatory requirement.
- Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
- Development and validation of assays to be governed per departmental SOP.
- Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
- Ensure GLP and GCP compliance is maintained in laboratory during study support
- BSc with at least 5+ years relevant GLP/GCP laboratory experience, with a focus on ligand binding assay development in biological matrix (plasma, serum) and/or cell-based assay experience; MSc with at least 3+ years relevant GLP/GCP laboratory experience with a focus on ligand binding assay development in biological matrix (plasma, serum), cell-based assay experience. MSc with foreign degress equivalent in chemistry, biology, or related field with relevant laboratory experience described above and/ or on PCR assays.
- Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
- Industry experience with a focus in biotherapeutics and a strong record of scientific achievement.
- Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms.
- Skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents.
- Experiences worked on qPCR or ddPCR assay development detect copies of mRNA and DNA in biological matrix (plasma, serum) a plus .
- Excellent communication and presentation skills .
This is a laboratory based position, the activities may include light l ifting, sitting, standing, walking, bending. Ability to perform mathematical calculations and ability to perform complex data analysis are required. Other Job Details
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Research and Development