07 Nov
|
Alliance Pharma
|
Cannon Hill
07 Nov
Alliance Pharma
Cannon Hill
Key Responsibilities:
- Design, develop, optimize and validate ADA and neutralizing antibody immunoassays on ELISA or MSD platforms.
- Independently troubleshoot assay performance issues and implement solutions.
- Lead method transfer, qualification and validation in line with regulatory guidelines (e.g., FDA, EMA, ICH M10).
- Ensure all laboratory work complies with Good Laboratory Practice (GLP) and internal SOPs.
- Maintain accurate experimental records, review data and contribute to technical reports.
- Train and mentor junior scientists.
- Work closely with clients, project teams, study directors and QA to deliver studies on time and to a high standard.
- Contribute to continuous improvement of laboratory processes, documentation and best practices.
- Take part in scientific discussions, audits and client meetings as needed.
- Perform other duties as required.
Required Qualifications:
- PhD in immunology, biochemistry, analytical chemistry or a related field with 3+ years of relevant industry experience, or an MSc with 5+ years.
- Proven experience developing and validating immunogenicity (ADA and NAb) methods in line with FDA and industry guidelines.
- Experience developing and validating PK or biomarker assays is advantageous.
- Solid troubleshooting skills, including root-cause identification.
📌 Senior Scientist I - IA (Cannon Hill)
🏢 Alliance Pharma
📍 Cannon Hill