Education Minimum Requirement:
• MS or Ph.D. in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry
Required Experience and Skills:
• A minimum of 5 (for MS) years of clinical laboratory or pharmaceutical industry experience or a doctoral degree (Ph.D.) in a related discipline (e.g. analytical chemistry, biochemistry, etc.).
• A minimum of 5 years of hands-on direct experience in immunoassay-based assay development (this experience does not need to be post-graduate)
• Strong experience in the handling of biofluids (plasma, serum, CSF, etc) for clinical biomarker bioanalysis.
• Strong interpersonal, verbal and written communication skills
• Motivated and able to work independently.
• Ability to execute within a matrixed organization and collaborate with cross-functional teams.
Preferred Experience and Skills:
• Broad knowledge of the drug development process and translational medicine
• Hands-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development.
Note: Key skills: Immunoassay, MSD experience and ELISA.
Job Description
Translational Molecular Biomarkers (TMB) is responsible for the development and execution of clinical biomarker assays across all therapeutic areas and all phases of clinical development within our company's research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms drug action and patient response.
The Immunoassay group within the TMB organization is seeking a highly motivated candidate to join our team.
The individual will play a critical role in the development and validation immunoassay-based assays that are deployed in support of clinical trials.
The candidate for this Senior Scientist position should have strong technical expertise in immunoassays for protein quantitation and enzymatic activity assessment in biological samples. The candidate should have a strong interest in lab-based assay development, validation, and clinical sample analysis. In addition, the candidate should have interest in collaborating closely with out-sourcing partners on the scientific oversight of assays that support our pipeline.
The individual will have the following responsibilities:
• Develop and validate immunoassay-based assays within TMB for all therapeutic areas and all phases of clinical development.
• Assist in the transition of biomarker assays from Basic Research to Clinical use by providing technical guidance on fit-for-purpose assay validation.
• Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.
• Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs.
• Serve as a subject matter expert in immunoassay-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
