Description
DESCRIPTION
Responsible for the development and qualification of robust and reliable ligand binding assays suitable for characterizing the disposition and immunogenicity of biotherapeutics and quantitation of biomarkers in various matrices using a range of potential screening platforms and assay techniques.
Responsible for the design, troubleshooting, qualification and conduct of the assay to support biotherapeutic programs.
Timely delivery of concentration and immunogenicity data to PDM BioTX principal investigators and other partners.
Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for discovery and development stage assets.
Design, develop and implement ligand binding assays (eg ELISA, ECL detection, Gyrolab) to measure protein of interest concentration and detect the presence of anti-drug antibody in a fast paced and dynamic 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.
SKILLS:
QUALIFICATIONS
Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms and demonstrated analytical problem solving skills.
Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics.
Proven ability to generate high quality data against challenging time lines
Ability to communicate across site and discipline to enable maximum impact of bioanalytical science.
Knowledge of biotherapeutic structure, pharmacology, disposition and immunogenicity and the impact on assay selection.
Ability to author technical documents such as data summary reports and analytical procedures. Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.
Strong organizational and time management skills in order to balance working on multiple projects in parallel.
EDUCATION
BSc with at least 3+ years relevant experience, with a focus on ligand binding assay development; (R2); MSc with at least 2+ years relevant experience with a focus on ligand binding assay development (R3).
Industry experience with a focus in biotherapeutics and a strong record of scientific achievement; excellent communication skills.
Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms. Proven presentation skills.