Senior Director of Quality Control

A company is looking for a Senior Director, Analytical Development and Quality Control.

Key Responsibilities

Lead the design and implementation of analytical methods for characterization, release, and stability testing

Oversee lifecycle management of analytical methods and ensure compliance with regulatory standards

Collaborate with cross-functional teams to align analytical strategies with development and manufacturing objectives

Required Qualifications

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 12+ years of experience, or M.S. with 15+ years in relevant fields

Proven leadership in analytical development and QC within global CDMO / CMO networks

Extensive experience with method development, qualification, and validation

Deep technical expertise in analytical chemistry for small molecules and biologics

Demonstrated success in regulatory interactions and authoring analytical sections of submissions