Senior Scientist R&D

About the role

We are looking for a Senior Scientist within the Molecular Assay Development group to co-lead the design and development of assays in support of IVD & CDx programs.

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
• Affordability and compliance with project critical path and respond appropriately to changing priorities
• Affordability and compliance with project critical path and respond appropriately to changing priorities
• Affordability and compliance 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
• Proactively improve efficiency, quality and effectiveness of R&D efforts

Qualifications

• 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
• Demonstrated technical and project leadership expertise
• Good organization skills, detailed oriented mindset
• Ability to thrive in a fast paced environment
• Team driven

Pay

$94,000.00-$135,000.00