Stability Lead, Analytical Development

Torrey Pines Solutions; San Diego (CA); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Torrey Pines Solutions is seeking a Manager or Senior Manager, Stability to join the Analytical Development group in San Diego, CA. The role leads stability studies across pipelines, reviews CMO protocols, and ensures data integrity in EDMS.

Collaboration with QA, CMC, and cross-functional teams supports regulatory submissions. Ideal candidates will have 5+ years in pharmaceutical analytical development, strong cGMP/ICH knowledge, and hands-on experience with modern analytical techniques.

Competenze

• Experience in analytical development within the pharmaceutical industry.
• Strong understanding of cGLP/cGMP principles and ICH guidelines.
• Hands-on analytical chemistry knowledge and problem-solving ability.
• Demonstrated leadership, teamwork, and communication skills.
• Experience with EDMS systems and quality documentation processes.

Mansioni

• Manage all development and GMP stability studies for pipeline projects and maintain the stability schedule.
• Review and approve stability protocols, reports, and raw data with timely delivery.
• Enter stability and SOP documentation into EDMS and manage document control.
• Coordinate with QA to establish retesting periods and change controls for documents.
• Coordinate with CMOs and provide input on stability investigations (OOE, OOS).
• Perform stability trending analysis and update the CMC team on status and issues.
• Assign retest or expiry dates based on data and guidelines.
• Assemble stability data tables and contribute to regulatory submission sections.
• Contribute to setting specifications for drug substances, intermediates, and materials.

Conoscenze

Analytical development

cGLP/cGMP

ICH guidelines

Leadership

Data analysis

Communication

Formazione

BS/MS degree in chemistry or pharmaceutics or equivalent

Strumenti

Veeva Vault

Descrizione del lavoro

Torrey Pines Solutions is seeking a Manager or Senior Manager, Stability to join the Analytical Development group in San Diego, CA. The role leads stability studies across pipelines, reviews CMO protocols, and ensures data integrity in EDMS.

Collaboration with QA, CMC, and cross-functional teams supports regulatory submissions. Ideal candidates will have 5+ years in pharmaceutical analytical development, strong cGMP/ICH knowledge, and hands-on experience with modern analytical techniques.