Bridgewater, New Jersey

Senior Scientist, Product Development

Bridgewater, NJ

Direct Hire/Salaried

 

The Product Development team is looking for a Senior Scientist with specialization in automation and liquid handling to be 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. This team supports the existing commercial diagnostics and is also responsible for the improvement & development of current and new tests, respectively.

 

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 experience in liquid handling robotic platforms, relevant scientific training, 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.

 

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.
  • Configure, program and troubleshoot laboratory automated platforms.
  • Optimize automated processes to improve efficiency, throughput, robustness and quality.
  • 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 on the new technologies/assays undergoing feasibility testing.
  • 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.

 

Education/Experience:

  • PhD in relevant scientific discipline (or equivalent) with minimum 2 years work experience (preferably in product development); or Master’s Degree with a major in biological sciences or medical technology with at least 5 years of pertinent research and development experience.
  • Minimum 2 years hands on experience in automation and liquid handling.

 

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


Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Bridgewater, New Jersey

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