Associate Director - Mass Spectrometry

Overview

Scientific leader responsible for bioanalytical and biomarker strategy and delivery of regulated PK, immunogenicity, and biomarker data for clinical trials. Expert in one or more technologies including mass spectrometry, partnering across global and cross-functional teams.

What you'll do

• Lead bioanalytical strategy and contribute to biomarker strategy for multiple global clinical development programs.
• Independently design and execute bioanalytical and biomarker deliverables as the SME, ensuring regulated compliance.
• Provide technical oversight of bioanalytical vendors for method development, validation, lifecycle management, and clinical sample testing.
• Partner with Quality to support vendor qualification, audit readiness, and GxP/regulatory adherence.
• Review PK, immunogenicity, and biomarker results and contribute to regulatory submissions and CSR-relevant documentation.
• Draft responses to health authority questions related to PK, immunogenicity, and biomarkers.

What you'll need

• PhD with 10+ years of experience, or MS with 16+ years, or BS with 18+ years (including 7+ years of industry experience).
• Deep bioanalytical chemistry and immunology expertise in drug development settings.
• Expertise in one or more biomarker technologies (e.g., immunoassays, genomics, flow cytometry, cell-based assays, LC-MS/MS).
• Knowledge of global/EU/Poland regulatory guidance for method validation and clinical/preclinical sample testing.
• Ability to operationalize local/EU/global regulatory expectations into fit-for-purpose bioanalytical plans with inspection readiness and data integrity.
• Experience overseeing Poland/EU laboratories/CROs, including vendor selection/qualification support and CAPA follow-up.
• Fluency in English; Polish proficiency preferred.

Details

• Role mentions a Poland-based regulatory/quality SME context for bioanalysis/biomarkers.
• Location listed as Bengaluru (IND) - Research and Development.