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 plaforms.
• 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:
• In depth knowledge of Immunoassay/Ligand Binding assays including method development and validation is essential
• Extensive knowledge of practical aspects of Bioanalytical techniques and Bioanalytical Method Validation to ICH M10 guidance
• Experience of practical aspects of Immunogenicity / Anti-drug antibody techniques and validation to FDA/EMA guidance.
• Expertise in performing pharmacokinetic / Immunogenicity assays using a variety of analytical platforms including ELISA, ECL and Gyrolab.
• Able to assimilate and develop new techniques and technologies within laboratory, in line with business need.
• Detailed understanding of theoretical basis of the Bioanalytical techniques, supporting a diverse range of client requirements for biopharmaceuticals.
• To maintain a “state of the art” knowledge in relevant Bioanalytical technologies and platforms.
• Enthusiasm and ability to generate and technically review multi-technique bioanalytical reports.
• Ability to problem solve technical challenges autonomously.
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
The role is a permanent full time role based at Hexagon Tower, Blackley, North Manchester where the site offers a variety of on-site amenities including a gym and restaurant. In addition to generous paid annual holidays we proactively support work life balance for all our employees by operating flexible working opportunities.
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.
To be filled by Talent recruiting team To be filled by Talent recruiting team
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