Scientist, Product Development
JOB DESCRIPTION

We are currently seeking an extraordinary, highly motivated individual to join our Research and Development team, with a focus on development and evaluation of emerging technologies for tissue and cell-free DNA liquid biopsy approaches. The successful candidate will assess and optimize laboratory-based diagnostic analyses for research and clinical use following guidelines of regulatory agencies for academic, biotechnology, and pharmaceutical clients.

KEY RESPONSIBILITIES
  • Conduct daily activities independently, making technical decisions with understanding of technical and business needs.  This includes:
    • Design, execution, and analysis of experiments for (i) optimization, (ii) troubleshooting, (iii) feasibility, and (iv) verification and validation of emergent genomic and allied technologies
    • Ownership of design control documents, such as writing feasibility, verification and validation protocols and reports
    • Facilitate product requirement and risk management process with the development team and in collaboration with key stakeholders
    • Own the technical content for all product labeling, ensuring alignment with key stakeholders at the project team level
    • Work with the R&D team to ensure clear communication between assay processing to data analyses to report delivery and technical reviews and design reviews
    • Present data to technical and project teams sufficiently to enable data driven decisions
    • Strong understanding of core technology and how to adapt necessary design control processes to the technology and business needs
    • Manage several projects at once and master new concepts and skills quickly with attention to detail and accuracy
    • Anticipates risks and migrations, determines priorities, provides subject matter expertise
  • May act as a project team member or technical lead
  • Works collaboratively with PMO, quality, regulatory, and the R&D team to execute project deliverables
  • Works with CSS for training external sites and creating training material for products in development
  • Works with regulatory for robust pre-Sub content and FDA communications/interactions and FDA submission
  • Works with pharma partners as needed to ensure requirements and scope is clear for CDx programs
  • Other responsibilities as required for successful R&D operations
REQUIRED EDUCATION AND EXPERIENCE
  • PhD with 2+ years of relevant experience (not including post- doc), OR Master’s degree with 5 years of relevant experience OR Bachelor’s degree with 7+ years of relevant experience
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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