Job Description:

Director – Immunoassay Development

On-site/ Hybrid | London/Stevenage | Permanent

Talentmark is working with an innovative, early-stage diagnostics company developing next-generation at-home testing technology.

We are looking for an Associate Director / Director – Assay Development to take ownership of assay development and help shape the company's scientific direction. This is a hands-on leadership role, taking assays from initial design and optimisation through to validation and commercialisation.

The role is currently based in Stevenage, with the longer-term expectation that the company will be London-based. Candidates should therefore be comfortable commuting to Stevenage initially, with longer-term transition to London and hybrid working. 

Key Responsibilities

• Lead the design and development of quantitative immunoassays.
• Drive optimisation of sensitivity, precision, reproducibility and stability.
• Design and execute assay development and validation studies.
• Maintain robust documentation aligned with regulatory and technical-file requirements.
• Establish high standards for data integrity, experimental rigour and statistical analysis.
• Manage external scientific collaborators and advisors.

Your Background:

You are an experienced immunoassay scientist with a strong industry leadership background in diagnostic assay development, with track record in taking assays through validation towards commercial release. 

Essential Experience

• PhD in Biochemistry, Analytical Chemistry, Bioengineering, Biomedical Science or a related discipline.
• Industry experience in diagnostics or assay development (5 yrs+)
• Strong hands-on expertise in immunoassay development, particularly ELISA, with a good working knowledge of enzymatic assays.
• Experience translating laboratory immunoassays into point-of-care, lateral-flow, biosensor or microfluidic cartridge formats.
• Experience with low-concentration analyte measurement
• Proven experience developing diagnostic assays through validation and commercial release.
• Practical experience working with human biological samples (blood, saliva or urine).

Desirable Experience

• Experience developing steroid or peptide hormone assays.
• Familiarity with freeze-drying / lyophilisation for reagent stabilisation.
• Knowledge IVD technical-file preparation for CE, UKCA or FDA submissions.
• Experience building or leading a laboratory/science team.
• Experience working with aptamer technology.

What's on Offer

• The opportunity to take diagnostic assays from concept through validation and towards market.
• A senior, hands-on role within an ambitious early-stage company.
• Competitive salary and share equity options scheme. 

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 199 429 in all correspondence.