A degree in pharmaceutical sciences, biochemistry, chemistry, biological sciences, or equivalent industry experience in bioanalysis.
Extensive experience leading the development, validation, and application of ligand-binding assays to support PK, biomarker, and immunogenicity (ADA and NAb) studies across preclinical and clinical programmes.
Strong scientific judgement in selecting fit-for-purpose bioanalytical platforms to meet sponsor requirements and regulatory expectations.
Proven experience operating within a GxP-regulated CRO environment.
In-depth knowledge of global regulatory guidance and industry best practice for bioanalytical method validation of PK, biomarker, and immunogenicity assays.
Demonstrated scientific leadership, including mentoring scientists, setting bioanalytical strategy, and collaborating effectively with cross-functional teams.
Familiarity with the financial aspects of projects including time and materials costs
Responsibilities
You'll also have:
A degree in pharmaceutical sciences, biochemistry, chemistry, biological sciences, or equivalent industry experience in bioanalysis.
Extensive experience leading the development, validation, and application of ligand-binding assays to support PK, biomarker, and immunogenicity (ADA and NAb) studies across preclinical and clinical programmes.
Strong scientific judgement in selecting fit-for-purpose bioanalytical platforms to meet sponsor requirements and regulatory expectations.
Proven experience operating within a GxP-regulated CRO environment.
In-depth knowledge of global regulatory guidance and industry best practice for bioanalytical method validation of PK, biomarker, and immunogenicity assays.
Demonstrated scientific leadership, including mentoring scientists, setting bioanalytical strategy, and collaborating effectively with cross-functional teams.
Familiarity with the financial aspects of projects including time and materials costs