Sr. Research Scientist (Immuno Assay Development)

This position reports directly to the Director of Research and Development. Key researcher and project leader responsible for the research and development of novel products for use in the medical diagnostic industry. The emphasis is on development and validation of immunoassay tests across various assay platforms. Experience with biomarker discovery, new product development, assay development and validation of laboratory-developed tests (LDT), lateral flow strip tests, and multiplex assays in the context of Design Control is preferred. Experience with either CLIA, CLSI, or regulatory guidance documents and industry white papers is a plus.

This position entails significant bench work. Responsibilities include designing, executing, and documenting experiments, data analysis and interpretation, and summarizing and communicating findings to peers and Management through PowerPoint presentations and written reports. Excellent communication skills are required. Managing projects to milestones and timelines is a must. This position will lead to R&D commercial assay development using Design Control including feasibility, development, transfer to manufacturing, and clinical validation. This position will work in a fast-paced, dynamic team environment, and will act as a mentor to junior staff. May supervise 1-2 technicians/scientists.

• Project leader – commercial clinical LDT diagnostic assay development. Develop work plans consistent with timelines and milestones. Plan, initiate, direct, and successfully execute scientific research activities
• Independent leader requiring minimal levels of supervision and direction from management. Will serve as a leader and mentor to junior scientists/professionals to achieve project goals. May supervise a small number of technical staff
• Accountable for R&D responsibilities on cross-functional teams
• Responsible for R&D aspects of commercial assay development using Design Control including compilation of the design history file
• Write technical protocols and reports, specifications, and other mandatory documents for regulatory submissions
• Investigate feasibility
• Propose solutions and course(s) of action consistent with project and company goals
• Maintains an on-going surveillance of marketing, scientific, medical, and patent literature to stay abreast of new developments and products that may impact CD Diagnostics’ business
• Provides expert technical advice on competitor products, new products, and scientific concepts that may lead to new products
• Represent the company via presentations to groups of experts, societies, regulatory bodies, and scientific meetings and/or publishes papers in scientific journals
• Maintain relevant scientific and medical knowledge by attending conferences, courses, and meetings
• Technology scouting by monitoring various trade publications, journals, and university websites and disseminating this information to interested parties within the organization
• Writes invention disclosures describing patentable inventions arising from work done

• Solid understanding and knowledge of immunochemistry, immunoassays, and bioassays
• Experience with immunoanalytical and protein methods (ELISA, Lateral Flow, Luminex, Western Blots, SDS-PAGE, etc.)
• Experience in antibody and/or protein purification, conjugation, and analysis
• Demonstrated technical skill and experience in assay design, development, optimization, and validation
• Experience in the development and launch of commercial diagnostic tests
• Capable of performing laboratory testing and solving a variety of complex analytical analysis of key products
• Apply statistical rigor to experimental design and data analysis. Excellent analytical and problem-solving skills
• Highly motivated team player with strong organizational and communication skills
• Create and manage project timelines. Possess strong time-management skills and ability to multi-task
• Demonstrates ownership for integrity of own work and the work of the project team
• Provide scientific leadership and technical expertise. Serve as a scientific advisor and mentor for other group members in particularly junior scientists
• Has a good working knowledge of industry diagnostic guidelines (CLSI, CLIA, FDA, etc.)
• Good communication skills (written and verbal)
• Serves as a specialist and consultant in immunoassay development and validation. Knows whom to contact within and outside the organization for answers
• Has experience of working and interfacing with external labs, opinion leaders, and business partner collaborators

• Minimum educational requirement is an MS and/or PhD preferred in relevant Life Science discipline, such as Biochemistry, Immunology, Biology, Microbiology, Cell Biology with complimentary work experience.
• An advanced degree or some experience in the field of IVD is preferred

Up to 15%

EOE/M/W/Vet/Disability