Manager/Senior Manager, Stability

Torrey Pines Solutions; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical development

cGLP/cGMP

ICH guidelines

Leadership

Data analysis

Communication

Education

BS/MS degree in chemistry or pharmaceutics or equivalent

Tools

Veeva Vault

Job description

About the job Manager/Senior Manager, Stability

We’re looking for an Manager or Senior Manager, Stability to join the Analytical Development group. This position reports to the Director, Analytical Development. This is a newly created position due to company growth.

ESSENTIAL JOB FUNCTIONS:

• Manage all development and GMP stability studies for pipeline projects, including those for regulatory starting materials, intermediates, drug substances and drug products, and maintain the stability schedule for each study.
• Propose appropriate stability study design per material and project needs, review and approve CMO-generated stability protocols, stability reports and associated raw data records within agreed time frame.
• Enter all related stability and SOP documentation into EDMS and manage document control aspects for stability and related QC elements.
• Coordinate with Quality Assurance to establish retesting and expiration periods and change controls for all specification documents for drug substance, drug product, and clinical trial materials as subject matter expert.
• Coordinate with CMOs and provide technical input on stability-related investigations (OOE, OOS, etc.) to ensure each investigation is conducted and completed per applicable SOPs.
• Perform stability trending analysis and keep CMC team updated on study status and issues.
• Assign and document retest period or expiry date based on available stability data and applicable guidelines.
• Assemble stability data tables, write the stability sections, and contribute to the reviews for regulatory submissions.
• Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.

JOB REQUIREMENTS:

• BS/MS degree in chemistry or pharmaceutics or equivalent.
• 5+ years of relevant working experience in analytical development in pharmaceutical industry.
• Good understanding of cGLP/cGMP principles and ICH guidelines.
• Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
• Working knowledge of EDMS quality systems such as Veeva Vault.
• Detail-oriented and ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Have both broad and in-depth knowledge as well as hands on experience in modern analytical chemistry techniques. Outstanding problem solving abilities.
• Strong leadership, teamwork, organization, and collaboration skills.
• Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
• Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.