Director of Analytical Sciences

Job Summary

A company is looking for a Director, Analytical Sciences.

Key Responsibilities:

• Oversee analytical development and quality control activities for biologics, including method development and lifecycle management
• Act as a subject matter expert for analytical assays, contributing to regulatory submissions and continuous improvement initiatives
• Lead method transfer, qualification, and validation at CDMO laboratories, ensuring compliance with regulatory standards

Required Qualifications:

• Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline
• 10+ years of biopharma industry experience in analytical development and quality control for protein biologics
• Experience supporting regulatory submissions (IND, CTA, BLA) with expertise in method development and validation
• Proven leadership skills with experience in managing biologics program deliverables
• Experience in a small company or start-up environment is a plus