The Scientist within the Immunoassay group plays a critical role in the development and validation of clinical biomarker assays across all therapeutic areas and phases of clinical development. This position is central to confirming therapeutic target engagement and understanding drug mechanisms and patient response. You will provide technical expertise in protein quantitation and enzymatic activity assessment while collaborating with both internal teams and external outsourcing partners.
Primary Responsibilities
- Assay Development & Validation: Lead the creation and validation of immunoassay-based assays for deployment in clinical trials.
- Technical Guidance: Assist in the transition of biomarker assays from Basic Research to clinical use by providing guidance on "fit-for-purpose" validation.
- Clinical Execution: Interface with scientists and physicians in early and late-stage clinical development to execute biomarker strategies.
- Documentation & Reporting: Author scientific memos, final reports, and publications summarizing data; write and update laboratory SOPs.
- Subject Matter Expertise: Serve as an SME for immunoassay development, collaborating with project teams, biomarker leaders, and regulatory affairs on assay implementation.
- Scientific Oversight: Oversee out-sourced partners to ensure the scientific integrity of assays supporting the product pipeline.
Candidate Requirements
- 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
- Experience Level: * MS candidates: Minimum of 5 years of clinical laboratory or pharmaceutical industry experience.
- Ph.D. candidates: Doctoral degree in a related discipline (analytical chemistry, biochemistry, etc.).
- Hands-on Expertise: At least 5 years of direct experience in immunoassay-based assay development (includes pre-graduate experience).
- Bioanalysis: Strong experience handling biofluids (plasma, serum, CSF, etc.) for clinical biomarker bioanalysis.
- Collaboration: Ability to execute within a matrixed organization and collaborate effectively with cross-functional teams.
- Communication: Strong interpersonal, verbal, and written communication skills; highly motivated to work independently.
Preferred Experience and Skills
- Broad knowledge of the drug development process and translational medicine.
- Hands-on experience in clinical development/operations.
- Experience managing the implementation of biomarker assays in support of drug development.
