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

• 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

• Assay Characteristics Knowledge
• R&D Design Document Management
• Laboratory Validation
• Workflow And SOP Development
• Assay Performance Specifications Design
• Technical Issue Troubleshooting
• Project Budget Tracking

• Leadership Capabilities
• Good Organization Skills
• Detail Oriented Mindset
• Ability To Thrive In Fast Paced Environment