Scientist - Immuno

Intertek Pharmaceutical Services

Lancashire, United Kingdom

ABOUT YOU:

BSc/MSc/PhD in Biology/Chemistry (or related scientific discipline) is essential.
>3 years of relevant industry experience.
Performance of analysis by Immunoassay/Ligand binding assay is essential, utilising ELISA, ECL and/or gyrolab platforms.
In-depth knowledge of Immunoassay techniques with extensive experience of pharmacokinetic (PK)/Immunogenicity (ADA) analysis of biopharmaceuticals.
Laboratory experience of Pharmacokinetic (PK)/Immunogenicity (ADA) method development and validation.
Comprehensive experience of working in a GxP regulatory laboratory with strong understanding of GMP, GLP and/or GCP principles.
Strong method development and validation experience (ICH M10 Bioanalytical method validation, FDA/EMA Immunogenicity method validation).

ABOUT THE OPPORTUNITY:

Working within a diverse environment will provide an opportunity to utilise your skillset and knowledge to act as an independent member of the team. You will be expected to act as a lead investigator working across a vast array of projects which will range in scale, scope and timeline. You will take on accountability for becoming a technical reviewer and support with method validation, method optimisation and method development with some guidance It will be necessary to work as an established member of the business providing guidance and support to more junior members of the team and passing on your knowledge and experience.

ROLE ACTIVITIES INCLUDE:

Design, develop, and validate immunoassays such as ELISA, Western blot, and others.
Optimize assay conditions to ensure accuracy, reproducibility, and sensitivity.
Perform routine testing and quality control to ensure assay reliability.
Analyze and interpret assay data, providing detailed reports to stakeholders.
Collaborate with other scientists, R&D teams, and quality assurance to meet project goals.
Maintain a safe and compliant laboratory environment, adhering to regulatory standards.

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