Diagnostics project lead

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