The Scientific R&D Program Director will lead Clinical Genomic’s development and commercialization programs for molecular diagnostic assays used for oncology. The role will provide leadership and oversight throughout the product lifecycle, from assay development through regulatory approval and commercialization.  Additional responsibilities include ongoing process improvements for both regulated and commercial LDT’s. 

 

The position requires demonstrated technical proficiency, robust analytical thinking, collaboration in a cross-functional work environment and the ability to lead through complex development programs. A successful candidate will require a strong background in the fundamentals of regulated product development, optimization, scale-up and commercialization of molecular diagnostic tests, as well as technical support for existing products. Essential to this role is relevant scientific training and experience, a commitment to quality, strong work ethic,

attention to detail, ability to lead cross functional teams and track record of success. The ideal candidate must have experience working in regulated environments including FDA quality systems.

 

Essential Responsibilities include but not limited to:

  • Lead the development of complex molecular diagnostic assays
  • Oversee, lead and direct the scientific team
  • Understanding of assay processing and implementation of equipment/processes required for commercial scale-up
  • Ability to design and execute experiments in support of new product development including end-to-end assay performance, workflow/automation, process development, validation and transfer to commercial operations
  • Work in collaboration with clinical laboratory team, operations, corporate partners, vendors and contract manufacturers to commercialize new products
  • Develop technical specifications, quality control test methods and SOPs
  • Collaborate with scientists across the company developing technologies/assays
  • Ensure 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 degree in relevant scientific discipline (or equivalent) with at least 5 years’ experience in product development is preferred or Master’s degree with a major in engineering, biological sciences or medical technology with at least 8 years of pertinent research and development experience.

 

Skills/Knowledge/Cultural Fit:

  • Strong program management and leadership skills
  • Ability to be assertive and work well with others, fostering a culture of collaboration, teamwork and transparent communication with others, locally and globally
  • Knowledgeable of 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
  • Ability to adapt to changing business needs and flexible when required to achieve results
  • Must be 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