Manager/Sr. Manager - Bioanalytical

Meet
CA, United States
Full-time

Position Summary :

A clinical-stage biotechnology company is seeking an experienced professional to manage assay development and validation, focusing on bioanalytical assays for immunological diseases and cancer treatments.

This role involves both lab-based and vendor management responsibilities, including overseeing internal and external assay development, managing CROs, and ensuring compliance with industry guidelines.

Key Responsibilities :

  • Oversee assay development and validation for drug development programs.
  • Review protocols, procedures, and reports for scientific integrity and compliance.
  • Manage external vendors and CROs for bioanalytical assay development.
  • Provide technical support and troubleshoot issues.
  • Develop, optimize, and validate internal assays.
  • Analyze and report bioanalytical data for regulatory submissions.
  • Manage biosample collection and associated documentation.
  • Collaborate with cross-functional teams and mentor junior staff.

Qualifications :

  • Extensive experience in bioanalytical assay development, including PK, ADA, and flow cytometry.
  • Proficiency with bioanalytical platforms and cell-based functional assays.
  • Strong technical, project management, and vendor management skills.
  • Experience in early-phase clinical studies and lab requirements.
  • Ability to work in a fast-paced, flexible environment with clear communication skills
  • 30+ days ago
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