Associate Director, Regulated Bioanalysis

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Requirements:

• PhD in Chemistry, Biochemistry, Analytical Chemistry or related discipline.
• 6-8+ years of pharmaceutical industry experience in regulated bioanalysis.
• Experience with bioanalytical platforms: LC-MS/MS, ELISA, ECL, LBA, MSD, multiplex assays.
• Experience with outsourcing bioanalytical assays and CRO oversight.
• Knowledge of GLP, GCLP, and regulatory requirements.
• Strong communication and leadership skills.

Responsibilities:

• Lead and oversee bioanalytical activities for PK and immunogenicity assays at CROs.
• Provide scientific input for design and development of analytical methods.
• Collaborate with CROs to ensure timely delivery of milestones and maintain transparency.
• Work with internal and external SMEs to resolve issues during assay development.
• Effectively communicate results to stakeholders and contribute to regulatory submission packages.