Director of Product Development

San Mateo, CA

At PrognomiQ, we aim to develop and commercialize transformative tests for early detection and treatment of cancer and other complex diseases. To accomplish this, we are leveraging leading proteomics technology, including the Proteograph product suite from Seer Bio, in combination with other multi-omics assays to develop unprecedented molecular views of health and disease. We are a team of experienced and accomplished scientists supported by a group of leading investors in healthcare and technology. 

Would you like to be at the leading edge of molecular data generation and analyses that changes how cancer and other complex diseases are detected and treated? Or are you looking to bring innovative and disruptive solutions to market? If you answer “yes” to either of these questions, let us know by applying! 

Job Description

We are looking for an experienced Director of Product Development, to define and drive our multi-omics product development activities. This role reports to the Vice President of Research and Development and will be responsible for translating the discovery stage proteomic/metabolomic/genomic workflows into robust high-throughput clinical assays that can be deployed in a regulated CLIA/CAP lab.

Job Responsibilities

  • Define the overall product development strategy in partnership with R&D and Product Management
  • Coordinate the transition of discovery stage technology into a robust clinical assay
  • Participate in documentation of product and sub system requirements in partnership with Product Management
  • Responsible for Product Design & Development and implementation of Design controls
  • Provide strategic and technical leadership in developing plans for controls, automation, assay, reagent manufacturing/qualification
  • Responsible for leading wet lab activities related to all phases of product development including verification and validation studies
  • Partner with R&D in defining performance specifications for assay and instrumentation including guard banding studies and analytical/functional qualification tests
  • Partner with Quality leadership in performance and documentation of risk assessment (assay, instrumentation, software)
  • Collaborate with Data Science team to seamlessly integrate data analysis workstreams with the assay and automation workflows
  • Participate in cross functional teams developing the laboratory developed tests (LDT)
  • Participate in R&D meetings to provide feedback on designs with focus on robustness, quality and adaptability for future product development
  • Partner with stakeholders in regulatory filings 

Qualification

  • Ph.D. in Analytical Chemistry or Organic Chemistry or Biochemistry or related field
  • 8+ years of product development experience in life sciences with deep management experience leading and partnering with various aspects of R&D including assay, software, hardware and bioinformatics
  • Knowledge of state-of-art liquid chromatography and Mass spectrometry instrumentation and techniques
  • Experience with high throughput automation platforms and liquid handling systems
  • Ability to adapt in a fast-paced dynamic work environment  
  • Strong interpersonal skills with a track record of collaboration and teamwork
  • Excellent written and communication skills
  • Ability to proactively articulate issues to leadership and define mitigations

Equal Opportunity Employment 

PrognomiQ is an equal opportunity employer that celebrates diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.