Director, Analytical Development & Quality Control

The role

The Director of Analytical Development & Quality Control provides strategic and operational leadership for analytical development, characterization, and quality control. This role operates in a 100% outsourced environment to manage phase-appropriate analytical strategies for small molecule and parenteral drug products.

What you will do

• Lead and execute phase-appropriate analytical method development and testing strategies.
• Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.
• Ensure analytical methods support process development, formulation, manufacturing, and regulatory submissions.
• Support characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.
• 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.
• 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 supporting Drug Product development and manufacturing with emphasis on oral solid dose, parenteral, and pediatric formulations.
• Proven track record advancing products from early development through late-stage clinical development and/or commercialization.
• Demonstrated 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 oral solid dose characterization and phase-appropriate method development.
• Knowledge of ADC analytical characterization.
• Knowledge of ICH Q1, Q2, Q3, Q6, Q7, Q8, Q9, Q10, and Q14 guidance.
• Fluency with MS Word, Excel, PowerPoint, Project, iStability, and JMP (or similar statistical tools).

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 multi-state employer.