Head of Analytical Development & Quality Control

The role

The Head of Analytical Development & Quality Control provides strategic and operational leadership for analytical development, characterization, method validation, and quality control. This role manages phase-appropriate analytical strategies in a 100% outsourced environment for small molecule oral dose and parenteral drug product programs.

What you will do

• Build and lead a small team of analytical development and quality control chemists
• Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods
• Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions
• Establish and lead QC strategies across clinical manufacturing operations
• Oversee external GMP testing activities including raw materials, IPCs, release testing and stability programs
• Manage investigations involving OOS, OOT, deviations, and laboratory events
• Author and review analytical sections of regulatory submissions
• Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations
• Manage relationships with contract laboratories and CDMOs
• Oversee method transfers, validation activities, and technical governance of external laboratories

Required qualifications

• 12+ years (Ph.D.) or 15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience
• Deep experience in analytical development activities supporting Small molecule Drug Substance and Drug Product development and manufacturing
• Experience with oral solid dose, parenteral, and pediatric formulations
• Success in developing and validating discriminating dissolution methods for 1+ OSD tablets
• Track record advancing products from early development through late-stage clinical development and/or commercialization
• Success working with CDMOs and global development partners
• Knowledge of analytical method development and validation
• Knowledge of stability programs and specification setting
• Knowledge of quality control laboratory operations
• Knowledge of GMP analytical testing
• Knowledge of Small molecule drug substance characterization and phase-appropriate method development
• Knowledge of Oral solid dose characterization and phase-appropriate method development

Nice to have

• Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline
• Additional experience in development and implementation of analytical methods to support antibody/ADC manufacturing
• Experience with Biologics testing methodologies
• Experience in developing and commercializing drugs for oncology

About the company

Treeline Biosciences is a rapidly growing organization with a pipeline of small molecule Oral Dose and parenteral Drug Product programs.