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
