Director of Analytical Sciences
Virtual Vocations Inc, New York, NY, United States
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
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