Job Description

Position: Senior Director, Analytical Development

Location: San Diego, CA

George Higginson is currently searching for an experienced Senior Director, Analytical Development , with experience across all aspects of Biologics and/or Chemistry development , analytical and GMP Manufacturing , for a Biologics specialist CDMO .

The incumbent is responsible for managing a team of scientists that design, execute and document analytical development and pre-qualification projects in support of programs, providing technical and CMC regulatory leadership and guidance across their portfolio of programs. Additionally, this individual will be supporting both QC and AD.

Main Responsibilities:

• Optimizes processes to balance client requests with scope of work in a fast-paced environment.
• Leads development of analytical methods for drug testing and process monitoring.
• Designs pre-qualification strategies aligned with product specs and regulations.
• Provides guidance on capability, comparability, and formulation studies.
• Oversees method pre-qualification and transfer to quality control.
• Reviews analytical methods, validation reports, and stability protocols.
• Troubleshoots assays and improves analytical methods.
• Manages client relationships and technical discussions.
• Contributes to strategic planning and effective scientific communication.
• Sets goals for employees and department.
• Ensures compliance with regulations and company policies.
• Maintains expertise in drug development and regulatory requirements.

Requirements:

• Ph.D. in Science/Engineering or M.Sc. with additional experience.
• 7+ years (10+ with M.Sc.) in Development and/or cGMP manufacturing.
• Expertise in Biologics/Chemistry development, analytics, and GMP manufacturing.
• Experience with ADCs/Antibodies would be advantageous.
• Strong leadership, communication, and client relationship skills.
• Proven track record in drug discovery, development, and CMC/GMP processes.
• Experience in strategic planning for pre-BLA, process validation, and product launch.
• Financial and business acumen with CDMO experience in biomanufacturing.
• Skilled in method development, optimization, and validation for large molecules.
• Proficient in analytical technologies (HPLC, MS, CE-SDS, ELISA, and more).

This is a fantastic opportunity to be a key part of a cutting-edge CDMO, helping to shape the future of the organization while ensuring the process development, in-process monitoring, drug substance and drug product testing, is done to the highest of levels.

Apply today to take the next step in your leadership journey!

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