Sr. Scientist, Product Development

Who we are:

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment.

Mission of the role:

The Product Development Scientist will play a pivotal role in development activities for proprietary molecular diagnostic assays. This highly motivated individual will integrate input requirements from various stakeholders to develop prototypes and conduct design and development studies. This role will include both wet laboratory effort as well as study planning. Responsibilities include interacting with cross-functional teams from R&D, operations, quality, and regulatory affairs. This role requires the ability to communicate with stakeholders, mange projects, train others, develop research and analysis plans and protocols, interpret data, troubleshoot laboratory issues, and communicate results to diverse audiences both written and verbal.

Your day-to-day:

• Product Development: Coordinates with R&D and stakeholders to define and draft experimental plans, development records, and study reports.
• Work with quality mindset to assess critical quality attributes and critical process parameters
• Identify criticality of components/processes through risk assessment
• DOE experiments to establish boundaries
• Assay Improvement: Identification of alternative approaches, troubleshooting, and technical decision making.
• Develop and maintain effective working relationships with counterparts in other functional areas (e.g. Medical Affairs, Project Management, Commercial) to collect requirements and business needs.
• Identify and manage consultants that support study design, analysis, and presentation of scientific content.
• Prepares protocols, performs data analysis, interprets results and prepares reports.
• Maintains knowledge of scientific technological developments with an emphasis in molecular biology to identify new processes or procedures by reading current literature.
• May attend technical conferences or seminars.
• Contribute to the intellectual property portfolio of the company by implementing innovative and creative ideas to solve problems or improve current methods used in the clinical laboratory.
• Manages laboratory staff by providing technical guidance, training in molecular techniques and prioritization of work.
• Communicates with critical suppliers and maintains relationships with technical staff for the purposes of on-time delivery of project milestones.
• Supports project managers by establishing timelines and reporting status of assigned projects.
• Establishes and maintains Design History File and Quality Management documentation.
• Contributes ideas to improve team processes.
• Maintains lab and technical notebooks in a complete and consistent manner, following all regulatory and quality assurance requirements.
• Other tasks as assigned.

What it takes to do this job:

• Masters (M.S.) or Doctorate (Ph.D.) in molecular or cellular biology with 4+ years of relevant experience, required.
• Experience in the pharmaceutical or molecular diagnostic industry and clinical laboratory experience.
• Knowledge of routine testing procedures and common laboratory practices.
• Emphasis on nucleic acid handling, extraction, and purification from clinical samples, including cell-free DNA.
• Molecular techniques including PCR chemistry and design, qPCR and Next Generation Sequencing.
• Experience running and troubleshooting droplet digital PCR.
• Next generation sequencing bioinformatics.
• Experience in genotyping and variant calling.
• Statistics (Process and DOE, clinical).
• Ability to communicate and present complex scientific information to scientific and non-scientific audiences.
• Proven leadership abilities and project management, evidenced by history of successful project delivery.
• Strong analytical, problem solving, and decision-making skills.
• Previous industry experience in research and development.

Physical Demands:

• Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds.
• Ability to have full body movement
• All candidates must take a color vision test.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.

Who you are:

• You have a "do what it takes - no job is too small" team player and positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally.
• Your organizational skills, attention to detail, and ability to multi-task are excellent.
• You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to:

• Improve patient outcomes.
• Meaningfully impact the company's short-term and long-term success.
• Work collaboratively across all levels within the organization.
• Grow your role as you see fit.
• Learn everything there is to know about cancer diagnostic laboratory.
• Create an inspiring workplace.