- BSc / MSc/ PhD in Biology/Chemistry (or related scientific discipline) is essential.
- In-depth knowledge of Bioanalytical with over 5 years' experience using Immunoassay techniques for the analysis of biopharmaceuticals supporting pre-clinical and clinical analysis
- Comprehensive experience of working in a GxP regulatory laboratory with strong understanding of GLP and GCP principles.
- Strong method development and bioanalytical method validation experience following FDA/EMA guidance for PK and Immunogenicity assays
- You should also be able to demonstrate experience training, supervising and coordinating the work of more junior scientists
- Competent in all practical aspects of Immunoassay
- Experience in the application of Immunoassay to Pharmacokinetic (PK), Immunogenicity (ADA) and Biomarker analysis
- Worked on analytical systems supporting ELISA and Electrochemiluminescence (ECL)
- Providing analytical services to customers in the pharmaceutical and biopharmaceutical sectors in a GLP, GCP and GMP regulated laboratory.
- Method development and validation in accordance with industry guidance.
- Ability to work unsupervised, planning and performing analytical work, generating and interpreting data and generating reports when required.
- Experience working with biopharmaceuticals (eg. mAbs, Bispecifics, Peptides, Viruses) in biological matrices (eg. serum and plasma)
- Ability to assimilate and develop new techniques within the laboratory and work in new areas if required.
- Good understanding of theoretical basis of the techniques and their application to biopharmaceuticals.
- Ensuring bioanalytical studies meet the required quality standards and that are fit for purpose according to clinical phase and regulatory expectations.
- Ability to problem solve autonomously without relying on specific written procedures; draw on literature to formulate best plan of action involving staff from other teams as necessary
Analyst - Immuno Assay - Lancashire, United Kingdom - Intertek
2 weeks ago
Description
We need you to have:
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.
WHAT WE OFFER
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
Competitive salary/benefits
Development and career opportunities around the Globe
Working in a highly motivated team and dynamic working environment
In this opportunity you'll be joining our Chemical and pharma team, based at Intertek Pharmaceutical Services Manchester (IPSM), Blackley Manchester
We are an Equal Opportunity Employer who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.