ABOUT YOU
As 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:
1. BSc / MSc/ PhD in Biology/Chemistry (or related scientific discipline) is essential.
2. 3+ years of relevant industry experience.
3. Performance of analysis by Immunoassay / Ligand binding assay is essential, utilising ELISA, ECL and/or Gyrolab platforms.
4. In-depth knowledge of Immunoassay techniques with extensive experience of pharmacokinetic (PK) / Immunogenicity (ADA) analysis of biopharmaceuticals.
5. Laboratory experience of Pharmacokinetic (PK) / Immunogenicity (ADA) method development and validation.
6. Comprehensive experience of working in a GxP regulatory laboratory with a strong understanding of GMP, GLP and/or GCP principles.
7. Strong method development and validation experience (ICH M10 Bioanalytical method validation, FDA/EMA Immunogenicity method validation).
8. Experience of training, supervising, and coordinating the work of more junior analysts.
9. Good IT literacy skills.
10. Clear written and verbal communication skills with the ability to convey processes, results, and key messages effectively.
ABOUT THE OPPORTUNITY
The role is a permanent full-time position 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:
1. In-depth knowledge of Immunoassay/Ligand Binding assays including method development and validation is essential.
2. Extensive knowledge of practical aspects of Bioanalytical techniques and Bioanalytical Method Validation to ICH M10 guidance.
3. Experience of practical aspects of Immunogenicity / Anti-drug antibody techniques and validation to FDA/EMA guidance.
4. Expertise in performing pharmacokinetic / Immunogenicity assays using a variety of analytical platforms including ELISA, ECL, and Gyrolab.
5. Able to assimilate and develop new techniques and technologies within the laboratory, in line with business needs.
6. Detailed understanding of the theoretical basis of the Bioanalytical techniques, supporting a diverse range of client requirements for biopharmaceuticals.
7. Maintain a
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