Stability Program Lead for GMP Drug Substances & Products

Torrey Pines Solutions; San Diego (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A pharmaceutical development company based in San Diego, CA is seeking a Manager or Senior Manager of Stability to join their Analytical Development group. This newly created role involves managing development and GMP stability studies for pipeline projects, coordinating with Quality Assurance, and performing stability trending analysis. Ideal candidates should have a BS/MS in chemistry or pharmaceutics and at least 5 years of relevant experience in the pharmaceutical industry, particularly in analytical development.

Qualifications

• 5+ years of relevant working experience in analytical development in the pharmaceutical industry.
• Good understanding of cGLP/cGMP principles and ICH guidelines.
• Extensive background and hands-on experience in analytical chemistry techniques.

Responsibilities

• Manage all development and GMP stability studies for pipeline projects.
• Propose stability study design and review stability protocols.
• Perform stability trending analysis and keep CMC updated on study status.

Skills

Analytical development experience

Leadership skills

Teamwork

Detail-oriented

Problem-solving abilities

Education

BS/MS degree in chemistry or pharmaceutics

Tools

EDMS quality systems (e.g., Veeva Vault)

Job description

A pharmaceutical development company based in San Diego, CA is seeking a Manager or Senior Manager of Stability to join their Analytical Development group. This newly created role involves managing development and GMP stability studies for pipeline projects, coordinating with Quality Assurance, and performing stability trending analysis. Ideal candidates should have a BS/MS in chemistry or pharmaceutics and at least 5 years of relevant experience in the pharmaceutical industry, particularly in analytical development.