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

more information.


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

technologies/assays.

• 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.


Qualifications:


  • Authorization to work in the US indefinitely without restriction or sponsorship.


Education/Experience

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.


Skills/Knowledge/Cultural Fit

• 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

necessary.

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

skills

Ability to work within Quality systems under regulatory requirements.

Good documentation practices

Experience with automated liquid handling for nucleic acid extraction and

processing

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.