Director of Assay Development and Validation
Nexelis is an immunology-centric CRO specialized in clinical assay development in single and multiplex formats and sample analysis for low-, mid- and large-scale clinical testing. Our versatile team of scientists and technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filings of over 100 new molecular entities, including blockbuster biologics such as vaccines and complex large molecules.
- Our Seattle office focuses on Bioanalytical Services (PK, Immunogenicity ADA Assays, & Fit-for-Purpose Biomarkers), in addition to offering an extensive Biomarker Menu.
- We are seeking a highly motivated Director to head up the Bioanalytical Services team. This is a key growth area for Nexelis, and we are rapidly expanding staff, lab space, and office space to accommodate the growth. You’ll be at the leading edge of developing new assays that are critical to our clients, primarily large pharmaceutical companies and small biotechs.
- If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, we’re interested in hearing from you! Nexelis is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.
- Primary responsibility for the work produced by the R&D section of the laboratory
- Advise Director of Laboratory Services, Supervisors and other lab personnel with management responsibility
- Provide leadership in choosing the tactics used in the performance of R&D laboratory functions
- Review and respond to relevant quality assurance reports, including protocol deviations and trends in QC data that are identified by the QA department
- Communicate effectively with other Nexelis managers and executives, and with lab staff to facilitate the successful performance of laboratory work
- Positively represent Nexelis laboratory to clients, vendors, auditors, investors, news media, and other outside organizations
- Regularly review all laboratory operating procedures and direct and approve updates or delegates this task as appropriate.
- Work with Chief Scientific Officer, Business Development, laboratory scientist(s) & technologists, Director of Project Services, and QA Manager in the selection, validation and implementation of new lab tests
- Review the laboratory’s current technologies and monitor instrument productivity and service records
- Review safety reports, participate in identifying safety procedures requiring change, and work with the Safety Officer in delegating responsibility for planning and implementing change, and in monitoring the effectiveness of changes needed to maintain a safe laboratory environment
- Regularly review and update laboratory job descriptions, and provide input for laboratory staff performance reviews
- Provide direction for changes needed to reduce laboratory production costs
- Maintain revenue projection reports based on the most updated information on contracts and anticipated work
- Assist business development staff by providing information, and writing technical summaries for marketing, and the technical section of contract proposals, and contact potential clients in partnership with Business Development
Experience and Qualifications
- Professional certification in clinical laboratory science preferred
- Broad knowledge of health and clinical sciences
- Experience in diagnostic laboratory environment and/or diagnostic industry
- Research training, and demonstrated scientific and research expertise, preferably in a specialty complementary to Nexelis’ areas of expertise
- Financial and personnel management competence
PhD and training in clinical laboratory science preferred