Reagent Manufacturing Scientist

Reagent Manufacturing Scientist – IVD / Diagnostics

Play a hands-on role in building diagnostic products that impact real patient outcomes.

We’re supporting a growing life sciences manufacturing organisation as they expand their operations capability with the appointment of a

Reagent Manufacturing Scientist

.

Operating at the intersection of

R\&D and GMP manufacturing

, this role is ideal for someone who enjoys translating complex biochemical formulations into robust, scalable manufacturing processes.

You’ll be working on products that support the diagnosis and management of conditions such as infectious disease, oncology and metabolic disorders—so the output here genuinely matters.

Why this role is worth your attention

• Blend of science and manufacturing

– not stuck in pure QC or pure R\&D

• Opportunity to

own reagent production from first principles through to release

• Supervisory responsibility

with scope to influence team performance

• Exposure to

regulated IVD manufacturing (ISO 13485 / FDA standards)

• Work in a

growing, technically advanced CDMO environment

The role

You’ll take responsibility for the manufacture and control of complex biochemical reagents used in IVD products, ensuring quality, consistency, and compliance at every stage.

Key responsibilities include:

• Manufacturing

biochemical reagents from first principles

• Performing

incoming raw material testing and in-process QC

• Conducting

reagent and biosensor release testing

• Operating lab equipment such as

HPLC, FPLC, ELISA plate readers and particle analysis systems

• Writing and maintaining

SOPs, batch records and technical documentation

• Supporting and supervising

Manufacturing Technicians

• Leading or contributing to

technical investigations and root cause analysis

• Raising and managing

non-conformance reports (NCRs)

What we’re looking for

This role needs someone technically credible, detail-driven, and comfortable working in a regulated manufacturing setting.

You’ll likely bring:

• Degree (or equivalent experience) in

Chemistry, Biochemistry or a related discipline

• Strong experience in

reagent formulation and biochemical manufacturing

• Hands-on experience with

bioconjugation processes

• Familiarity with

GMP environments

(diagnostics, medical devices or pharma)

• Experience using

analytical and lab equipment

(e.g. HPLC, FPLC, plate readers)

• Proven ability in

technical problem-solving and root cause analysis

• Previous

supervisory or team leadership experience

Highly advantageous

• Experience in

IVD manufacturing or assay development

• Knowledge of

ISO 13485 and/or FDA 21 CFR Part 820

• Experience transferring

R\&D processes into manufacturing

• Exposure to

process optimisation or continuous improvement (e.g. Lean / Six Sigma)

The environment

You’ll be joining a

scaling, fast-moving CDMO

working with both UK and international clients.

Expect:

• A

dynamic, evolving environment

• High expectations around

quality and compliance

• A culture where

initiative and ownership are recognised

• Genuine opportunity for

development and progression

Flexibility is important—

shift working may be required

depending on production demands.

Interested?