Senior Scientist - R&D

Responsibilities Maintain overall knowledge of the assay characteristics Provide scientific leadership to cross‑functional teams Manage and lead generation of R&D design documents Lead validation team from project inception through launch including sample selection, hands‑on laboratory validation, establishing workflow and SOPs, and authoring validation plans and summaries Ensure activities are consistent with project critical path and respond appropriately to changing priorities Assist in developing and tracking project budgets Design assay performance specifications Ensure assay development process meets milestones and timelines Troubleshoot and solve technical issues Maintain compliant laboratory documents and procedures Proactively improve efficiency, quality and effectiveness of R&D efforts Requirements PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field with 3+ years industry experience -or- MS with industry experience commensurate with requirements Demonstrated leadership capabilities in assay development in an FDA regulated environment for IVD products under design controls Strong technical expertise and hands‑on experience with nucleic acid technologies with a preference towards NGS, PCR, and qPCR techniques Proven ability to apply principles of quality control and quality assurance to development activities Strong understanding of FDA, EUA, and other global regulatory requirements Good organization skills, detailed oriented mindset Ability to thrive in a fast paced environment Hard Skills Assay Characteristics Knowledge R&D Design Document Management Laboratory Validation Workflow And SOP Development Assay Performance Specifications Design Technical Issue Troubleshooting Project Budget Tracking Soft Skills Leadership Capabilities Good Organization Skills Detail Oriented Mindset Ability To Thrive In Fast Paced Environment #J-18808-Ljbffr Jobtailor