Manager/Senior Manager, Stability

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

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.