Senior Analyst – Immunoassay

Job title:

Senior Analyst – Immunoassay

Company

Intertek

Job description

Job Description:ABOUT YOUAs a Senior Analyst you will work as a senior member of the Laboratory with accountability for leading, managing and driving the TQA promise. You will demonstrate your expertise within Bioanalytical and have the confidence to provide support and guidance on specific techniques to both Colleagues and Clients.Required skills and experience:

• 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).
• You should also be able to demonstrate experience of training, supervising, and coordinating the work of more junior analysts.
• Good IT literacy skills.
• Clear written and verbal communications skills with the ability to clearly convey processes, results, and key messages and able to build rapport, quickly and effectively.

ABOUT THE OPPORTUNITYThe 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.Key activities:

• 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.
• Demonstrate innovative method development as required, drawing on literature as required, in line with business needs and opportunities.
• Demonstration of excellence in client communication and service.
• Working 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 OFFERJoin 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

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.

Expected salary

Location

Lancashire

Job date

Sun, 04 Aug 2024 00:53:56 GMT

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