Product Development Scientist

1 week ago


San Mateo, United States Theery Full time

As an early member of the multi-disciplinary scientific team, you will help drive the development of a platform for the scalable, high-throughput and reproducible multi-omics analysis of cancer and other complex diseases. Your expertise will provide a significant contribution to the scientific and technological direction of the proteomics that are core to our multi-omics platform development. You will work within a highly interdisciplinary team uniting scientists with a broad range of expertise and collaborate to integrate multiple omics signals into a full systems biology view of every patient as we discover, develop, and commercialize solutions to save patients' lives.


Our client is leveraging game-changing advances in proteomic methods with cutting edge next generation sequencing (NGS) technologies in order to revolutionize non-invasive diagnostics. Highly motivated experts passionate about creating disruptive diagnostic technologies for early disease detection are valued and critical to our success.


Duties:

  • Work with a multidisciplinary team of mass spec scientists, automation engineers, data scientists, software developers and clinical researchers to develop LDT and IVD products for early detection of cancer in liquid biopsy samples.
  • Provide technical expertise to support LDT and IVD submissions to regulating organizations.
  • Manage execution of various product development studies.
  • Assist in planning the strategy for product design, verification, validation, and technical transfer to CLIA lab.
  • Provide leadership in experimental design, execution, and data analysis.
  • Supervise testing to establish assay performance characteristics and support regulatory submissions.
  • Supervise activities of direct reports and help mentor other junior level team members.
  • Write detailed SOPs, protocols, and reports to support development of regulated products.
  • Manage relationships with CRO’s and CMO’s involved in the IVD development.
  • Evaluate and develop robust and economical methods to enrich low abundance analytes in plasma.

Requirements:

  • PhD in biochemistry, analytical chemistry, or related field with 2+ years (Scientist) or 8+ years (Sr. Scientist) relevant industry experience.
  • Prior experience in IVD product development required for Sr. Scientist level, strongly preferred for Scientist level.
  • Prior management experience required.
  • Experience with developing immunoassays highly desired, but not required.
  • Experience with targeted Mass Spec assays is plus, but not required.
  • Proven history of executing against timelines and reaching key milestones.
  • Must work well in a small team setting, with ability to work independently and collaboratively while meeting deadlines.
  • Highly organized, exceptional attention to detail and strong documentation skills.
  • Must be able to organize work, multitask and manage time effectively.
  • Excellent communications and presentation skills, as well as a desire to work across functional teams.
  • Desire to focus on breakthroughs in an exciting, fast-paced startup environment.
  • Ability and drive to solve practical problems.


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