Job Description
61 Serves as a member of the clinical study team and analytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
61 Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
61 Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
61 Contributes to the development of Best Practices, processes, templates, and policies.
61 Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection, ligand binding technologies & techniques or bioanalytical techniques commonly used for Biomarkers (as relevant to the role), global regulatory guidances & expectations, and industry best practices
Minimal/Must-have Requirement
61 Education: M.S. and B.S. degree in pharmacy, analytical chemistry, biology, biochemistry related fields.
61 Basic Qualification:0-3 years of industry or bioanalytical experience with PK and/or immunogenicity assay and biomarker assay development, validation, and sample analyses using chromatographic/mass spectrometry, ligand binding (ELISA and ECL) or other methodologies like flow cytometry, FISH and etc. (as relevant to the role).Conflict Management: Good at focused listening; can find common ground and get cooperation with minimum noise