Scientist, Assay Development (Non-PhD)
- Work under the guidance of a supervisor with high degree of independence.
- Responsible for the development of robust and reliable ligand binding assay suitable for the quantitation of biotherapeutics in various biological matrices.
- Responsible for the development robust and reliable ligand binding assay 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.
- 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 SOPs.
- Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
- Ensure GLP and GCP compliance is maintained in laboratory during study support
- Laboratory focused position. Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
- Design, develop and implement ligand binding assays using different platforms (e.g. ELISA, ECL, Gyros 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.
- Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
- Analytical problem solving
- Gathers input from colleagues, literature, and additional resources to assist in driving the project forward.
- BSc with at least 6+ years relevant GLP/GCP laboratory experience, specifically with a focus on ligand binding assay development experience in a biological matrix (plasma, serum), or a MSc with at least 4+ years of experience.
- Experience supporting large molecules.
- Industry experience and/or bioanalytical experience in a regulated environment is mandatory.
- Skills in GLP/GCLP/GMP compliant analysis including following SOP and provision of quality regulatory documents.
- Cell-based assay experience is preferred
This is laboratory based position, the activities involves Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis
Other Job Details:
- Last Date to Apply for Job: September 30th 2020
- Eligible for Employee Referral Bonus