Bioanalytical Scientist

PURPOSE:

- Responsible for the development and validation of robust and reliable ligand binding assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various matrixes using a range of potential screening platforms and assay techniques.
- Responsible for the design, validation and conduct of the assay to support biotherapeutic programs.
- Timely delivery of concentration and immunogenicity data to PDM BioTX principal investigators and other partners.
- Development and validation of assays to be governed per departmental SOP.
- Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
- Knowledge of GLP/GCP and working in a regulated environment is highly desirable.
- Develop and implement ligand binding assays (eg ELISA, ECL detection) to measure compound concentration
- Detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a dynamic environment.

SKILLS:

TECHNICAL REQUIREMENTS:

- Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
- Knowledge and hands on experience working under GLP/GCP regulations is highly desirable
- Ability to generate high quality data against challenging time lines.

QUALIFICATIONS:

- BSc with at least 1+ year relevant experience, with a focus on ligand binding assay development; preferably in a GLP/GCP laboratory
- Industry experience with a focus in biotherapeutics
- Skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents is highly desirable
- Attention to detail
- Peer Relationships
- Proven ability to deliver quality data to tight timelines.
- GLP/GCP knowledge desirable.
- Detail orientated.
- Good Laboratory Practices (GLP)