George Higginson is currently searching for an experienced Associate 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 x3 scientists that will develop and optimize analytical and bioassay methods to support upstream/downstream process development, in-process monitoring, and drug substance/product testing.
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.
- 5+ years (7+ with M.Sc.) in Development and/or cGMP manufacturing.
- Expertise in Biologics/Chemistry development, analytics, and GMP manufacturing.
- Experience with bioassays is essential.
- 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.
Featured benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
