Director, Immunoassay Development - Diagnostics & Point-of-Care

BioTalent are partnered with an innovative, venture-backed women's health diagnostics company looking to appoint a Director of Assay Development at a pivotal stage of growth. This is an opportunity to lead the scientific development of a next-generation diagnostic platform designed to transform how hormone-related conditions are monitored, understood and ultimately managed. The company is developing an at-home diagnostic technology capable of measuring multiple hormones over time, generating a far more complete picture than traditional single-point testing approaches.

With the engineering and device platform well advanced, the focus now shifts to the science behind the assays. They are looking for an experienced assay development leader who can define the strategy, build the function and help bring a novel diagnostic product from development through validation and towards commercialisation.

Why This Opportunity Stands Out

This is not a role where you inherit a large team, established processes and a clearly defined roadmap. Instead, you'll join an ambitious early-stage business where you will become the scientific leader responsible for assay development. You will work directly alongside the founders and play a key role in shaping:

• Assay development strategy
• Hormone panel roadmap
• Technical direction of the platform
• Scientific standards and processes
• Future team growth and capability building
• Product development decisions

The successful individual will have genuine influence on both the science and the future direction of the business.

The Role

As Director of Assay Development, you will be responsible for building and leading the assay development function. You will provide scientific leadership across the development, optimisation and validation of highly sensitive quantitative hormone assays while ensuring successful integration into the wider diagnostic platform. This role sits at the intersection of assay science, product development, engineering and diagnostics. Whilst the position is strategic in nature, it is not designed for someone who has completely stepped away from the science. The business is looking for a technically credible leader who remains close enough to the work to guide decisions, troubleshoot challenges and mentor future hires.

Key Responsibilities

• Define and execute the assay development strategy
• Lead development of quantitative hormone immunoassays
• Establish the scientific roadmap for future assay programmes
• Drive assay optimisation across sensitivity, specificity, precision, reproducibility and stability
• Oversee low-abundance analyte detection and assay performance improvements
• Support translation of assays into cartridge-based and point-of-care formats
• Lead analytical validation activities
• Review experimental design, data analysis and technical reports
• Establish development processes, documentation standards and best practices
• Work closely with engineering, regulatory and clinical stakeholders
• Act as the senior scientific authority for assay development within the company
• Mentor and develop future assay scientists as the team grows
• Support future recruitment and function-building activities

What We're Looking For

Essential

• PhD in Biochemistry, Analytical Chemistry, Biomedical Science, Immunology, Bioengineering or a related discipline
• Significant industry experience within diagnostics, IVD, medical devices, assay development or closely related sectors
• Deep expertise in immunoassay development
• Extensive hands-on experience with ELISA-based systems
• Proven experience leading assay optimisation and validation programmes
• Experience translating assays towards commercial diagnostic products
• Previous scientific leadership, programme leadership or functional leadership experience
• Strong stakeholder management and cross-functional collaboration skills
• Experience working with biological samples such as saliva, blood or urine
• Strong statistical analysis and experimental design capability
• Comfortable operating within a fast-paced startup or scale-up environment
• Ability to work on-site in Stevenage initially and Central London thereafter
• Right to work in the UK without sponsorship

Highly Desirable

• Previous Director, Associate Director or Head of Assay Development experience
• Hormone assay development expertise
• Steroid or peptide hormone assay experience
• Point-of-care diagnostics experience
• Saliva diagnostics experience
• Cartridge-based diagnostic development
• Biosensors, lateral flow or microfluidics experience
• Team-building and people leadership experience
• IVD, UKCA, CE-IVD or FDA-regulated product development experience
• Experience taking diagnostic products through commercial launch

Ideal Background

We are particularly interested in individuals coming from:

• Diagnostics and IVD companies
• Point-of-care diagnostics organisations
• Medical device and medtech businesses
• Biosensor technology companies
• Lateral flow developers
• Microfluidics and cartridge-based diagnostic platforms
• Women's health diagnostics companies
• Regulated healthcare product environments

The Person

You'll be someone who enjoys building rather than inheriting. You'll be equally comfortable discussing scientific strategy with founders, reviewing validation data with scientists and collaborating with engineers to solve technical challenges. Most importantly, you'll be excited by the opportunity to shape a function, influence a product and contribute to technology that has the potential to improve outcomes for millions of patients. If you're an experienced assay development leader looking for an opportunity where you can genuinely shape both the science and the organisation, I'd be happy to discuss the role in confidence.