Associate Director, Analytical Development

AL Solutions; San Diego (CA); On-site; USD 235,000 - 285,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading company in Biologics research is seeking an Associate Director, Analytical Development. This pivotal role involves managing a team to optimize analytical methods for drug testing and ensuring compliance with GMP standards. The ideal candidate will hold a Ph.D. and have significant experience in the field, contributing to strategic planning and product launches.

Qualifications

• 5+ years experience in Development and/or cGMP manufacturing.
• Proven track record in drug discovery, development, and CMC/GMP processes.
• Experience with bioassays and large molecules is essential.

Responsibilities

• Leads development of analytical methods for drug testing and process monitoring.
• Optimizes processes to balance client requests with scope of work.
• Oversees method pre-qualification and transfer to quality control.

Skills

Leadership

Communication

Client relationship management

Analytical methods development

Troubleshooting assays

Education

Ph.D. in Science/Engineering

M.Sc. with additional experience

Tools

HPLC

MS

CE-SDS

ELISA

Job description

Associate Director, Analytical Development

Associate Director, Analytical Development

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Direct message the job poster from AL Solutions

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

Referrals increase your chances of interviewing at AL Solutions by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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