The Senior Scientist provides technical leadership to the department within one or more modalities, strong knowledge guiding project planning and execution, problem solving, representing both client and R&D projects within the company and externally. Writing proposals and/or plans, works independently, consistently and accurately for complex or difficult tasks. Translates projects between departments including R&D and Clinical teams. The Senior Scientist performs either a greater number or more varied amount of complex or difficult tasks and assignments than the work performed by a Scientist. The Senior Scientist may also serve as the Project Manager and/or Operations Manager for assigned projects or R&D initiatives, supervise project deliverables, manage the sample and data collection process, data monitoring, and all associated project manager tasks.

Responsibilities:

• Independently designs and executes applications within the modality areas.
• Must demonstrate proficiency in all Core Responsibilities of a Scientist.
• Consistently and independently performs the more complex level of procedures and projects.
• Provides technical leadership, mentors and directs laboratory teams in performing project experiments.
• Represents the department in a diverse range of settings, including with other departments, clients, audits, vendors, and conferences.
• Provide the leadership on project design and feasibility studies.
• Performs the literature review, write project/product proposals or plans.
• Reviews new technologies in the market.
• Analyzes, presents data and project updates to the management team.
• Validate and translate new tests and/or new technology between R&D and Operations.
• Provides support to research collaborations, clinical trials and other department projects.
• Prepares high quality technical reports (including validation, verification, final project) and documentation including posters/papers, client presentations and technical content for marketing materials.
• Assist with departmental budgeting and/or administrative efforts.
• Familiar with CAP/CLIA and FDA (GCP or GLP as appropriate) requirements and knowledgeable with the specialty requirements within those organizations

Qualifications:

• Ph.D. in a life, physical or computer science or M.D. preferred; M.S. in a life, physical or computer science with related experience; BS in a life, physical or computer sciences
• Five or more years related laboratory or technical experience preferred
• Supervisory experience preferred
• Previous Regulatory experience preferred.