Associate Director,Analytical Development Job San Diego area,California USA,Science

Associate Director, Analytical Development Associate Director, Analytical Development

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Principal Recruiter | Biologics, CMC and Small Molecules | CDMO & Biopharma

Position: Associate Director, Analytical Development

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.

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

Seniority level

Seniority level Director

Employment type

Employment type

Full-time

Job function

Job function

Manufacturing, Research, and Science
Industries Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research

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Medical insurance

Vision insurance

401(k)

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