Diagnostics project lead

Diagnostics project lead

Full-Time On-site
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About Serova

Serova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. Knowing exactly what a patient's tumor and immune system look like, in depth, is what every vaccine starts from.

The role

We're building a small set of laboratory-developed tests (LDTs) with Azenta (GENEWIZ), made for cancer and cancer-vaccine patients. These aren't cheap, high-volume tests. They're built for depth: single-cell and long-read sequencing, 10,000x whole-exome from blood, and 100,000x large panels. You'll run that program with Azenta now, and plan how we bring the tests in-house once demand is there.

What you'll do

  • Turn what our clinical and vaccine teams need into test specs: assay, depth, sample type and turnaround
  • Own the day-to-day relationship with Azenta: scope, timelines, data handoffs, and holding them to quality and turnaround
  • Write and run the development and validation plan for each LDT, from feasibility to clinical use
  • Work with our bioinformatics team so the data comes back ready to analyze
  • Work out the regulatory path for each test (CLIA/CAP, and FDA or UK rules where they apply) with our regulatory and quality leads
  • Build the plan and business case for bringing the tests in-house

Who you are

  • An assay development scientist turned project lead
  • You've built and validated sequencing-based tests, not just run them
  • You can talk to a partner lab as a technical equal
  • You keep a multi-party program on one timeline
  • High agency, friendly and low ego

Requirements

  • Hands-on development or validation of a sequencing-based diagnostic assay (LDT, IVD or clinical research assay)
  • A PhD in molecular biology, genomics or a related field, or equivalent industry experience
  • Based in London or the San Francisco Bay Area, or willing to relocate
  • Authorized to work in the UK or US, or a realistic path to get there

What will make you stand out

  • You've taken an LDT through analytical validation in a CLIA/CAP lab
  • Ultra-deep or low-input sequencing: liquid biopsy, ctDNA, deep panels, UMIs and error suppression
  • Single-cell or long-read assays (10x, PacBio, Oxford Nanopore)
  • You've managed a sequencing service or CRO partner, ideally Azenta/GENEWIZ
  • Oncology or companion diagnostics background
  • Some regulatory knowledge: CLIA, CAP, FDA rules on LDTs and IVDs, UK IVD rules
  • You've set up or scaled an in-house sequencing lab

Details

  • Location: London or San Francisco
  • Type: Full-time

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Contact Details:

Serova Recruitment Team