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Torrey Pines Solutions
Manager/Senior Manager, StabilityTorrey Pines Solutions • San Diego, CA, United States
Manager/Senior Manager, Stability

Manager/Senior Manager, Stability

Torrey Pines Solutions • San Diego, CA, United States
2 days ago
Job type
  • Full-time
Job description

Manager/Senior Manager, Stability

We're looking for a 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.
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Manager/Senior Manager, Stability • San Diego, CA, United States

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