Under direction of the Product Development Manager, you will work as an integral part
of the new Development team in a fast-paced environment to develop and bring to
market molecular diagnostic tests for detection of circulating tumor DNA in blood. You
must have demonstrable technical proficiency, robust analytical thinking, collaboration
in a cross-functional work environment, and the ability to work independently on
complex issues. You will bring a strong understanding of the fundamentals of product
development, optimization, scale-up, and commercialization of molecular diagnostic
tests, as well as, technical support for existing products. Essential to this role are
relevant scientific training and experience, a commitment to quality, a strong work ethic,
attention to detail, ability to function independently, desire to move your team forward,
and track record of success. The ideal candidate must have experience working in
regulated environments such as CLIA and/or FDA. Visit http://clinicalgenomics.com/ for
Essential Responsibilities include but not limited to:
• Design and execute experiments in support of new product development including
end-to-end assay performance, workflow, and automation; process development,
validation, and transfer to Operations.
• Work in collaboration with clinical laboratory team, operations, other departments,
corporate partners, and contract manufacturers to commercialize new products.
• Develop technical specifications, quality control test methods, and SOPs to support
commercialization of new products.
• Collaborate with the Research team in Australia to be aware of developing
• Ensures all work adheres to established policies and procedures, prepares and
maintains detailed records of all experiment and results, and ensures protocols,
reports, and appropriate documentation are written to required standards.
• Assists in training of personnel on new procedures and/or equipment.
• Obtains training and understanding of all laboratory policies and procedures to fully
comply with all relevant laboratory CLIA, CAP, HIPAA, NY DOH, Quality
Management System, and infection control and OSHA Bloodborne Pathogen
guidelines and requirements.
• PhD in relevant scientific discipline (or equivalent) with at least 2 years experience in
product development is preferred; or Master’s Degree with a major in biological sciences or
medical technology with at least 5 years of pertinent research and development experience.
• Knowledge about real time PCR including practical experience
• Assay troubleshooting and optimization
• Experience with statistical analysis and DOE (preferable)
• Strong problem solving and analytical skills
• Ability to work independently: exercise sound judgment and escalate issues when
• Strong oral and written skills
• Ability to be highly productive and thrive in a fast-paced work environment.
• Highly detail oriented with effective time management, scheduling, and organizational
• Ability to work within Quality systems under regulatory requirements.
• Good documentation practices
• Experience with automated liquid handling for nucleic acid extraction and
• Experience planning, managing, and reporting experiments.
• Must be flexible, innovative, and self-motivated
Job Type: Full time
Location: 1032 US Highway 202/206, Bridgewater, NJ 08807
Authorization: Unrestricted authorization to work in the US indefinitely.