06 Nov
|
Alliance Pharma
|
Australia
06 Nov
Alliance Pharma
Australia
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 Positive 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.
Robust troubleshooting skills, including root-cause identification.
📌 Senior Scientist I Ia Cannon Hill (Australia)
🏢 Alliance Pharma
📍 Australia