Stability Coordinator
Aquestive Therapeutics
July 01, 2026
Remote friendly (Portage, IN)
United States
Operations
Job Summary:
Responsible for planning, coordinating, and overseeing execution and completion of the Stability Program for both Aquestive-owned and non-Aquestive-owned products. Includes setting testing strategy and initiating and managing all stability studies.
Responsibilities:
- Serve as a subject matter expert on ICH guidelines.
- Perform statistical analysis and track/trend stability study data.
- Create, maintain, and manage stability set down and pull schedules to meet internal SOPs and ICH standards.
- Manage stability scheduling tools and ensure timely communication for on-time testing, data reporting, and report generation.
- Define stability batch requirements/strategy and communicate with Production and other parties to meet annual commitments.
- Author stability protocols per annual commitments, ICH guidelines, agency filings, and business rules.
- Author stability summary reports; ensure statistical analysis and appropriate treatment of trends.
- Enter stability control chart data; identify trends (including OOS and ATR) and lead investigations as needed.
- Create data packages to fulfill Statements of Work with external contracts; ensure on-time delivery.
- Draft and coordinate Statements of Work related to stability through execution.
- Author stability summary requirements for inclusion in Annual Product Quality Review reports.
- Partner with Analytical R&D and CMC Development to author/review/report stability data for developmental products (clinical, bulk, pivotal/registration batches).
- Support stability sample testing and data analysis/review; assist with non-stability QC investigations and process improvements.
- Monitor stability chamber room environmental requirements and review documentation (e.g., logbooks).
- Author and maintain Stability Program SOPs.
Qualifications:
- 3+ years’ experience in a pharmaceutical analytical laboratory.
- BS/BA in a scientific discipline or higher.
Skills/Required Tools/Knowledge:
- Statistical analysis tools (e.g., Minitab).
- Stability systems or LIMS systems.
- Analytical testing equipment/procedures (including HPLC and Chromeleon).
- GMP regulations knowledge (as applied to manufacturing analytical laboratory).
- Strong technical writing, attention to detail, and communication skills; strong organizational skills.
- Ability to handle multiple competing priorities; independent, data-driven judgment.
- Advanced computer skills (Word, Excel, PowerPoint) and ability to learn new applications.
Application Instructions:
- Final candidate must complete a drug test and background check prior to employment commencing.
Responsible for planning, coordinating, and overseeing execution and completion of the Stability Program for both Aquestive-owned and non-Aquestive-owned products. Includes setting testing strategy and initiating and managing all stability studies.
Responsibilities:
- Serve as a subject matter expert on ICH guidelines.
- Perform statistical analysis and track/trend stability study data.
- Create, maintain, and manage stability set down and pull schedules to meet internal SOPs and ICH standards.
- Manage stability scheduling tools and ensure timely communication for on-time testing, data reporting, and report generation.
- Define stability batch requirements/strategy and communicate with Production and other parties to meet annual commitments.
- Author stability protocols per annual commitments, ICH guidelines, agency filings, and business rules.
- Author stability summary reports; ensure statistical analysis and appropriate treatment of trends.
- Enter stability control chart data; identify trends (including OOS and ATR) and lead investigations as needed.
- Create data packages to fulfill Statements of Work with external contracts; ensure on-time delivery.
- Draft and coordinate Statements of Work related to stability through execution.
- Author stability summary requirements for inclusion in Annual Product Quality Review reports.
- Partner with Analytical R&D and CMC Development to author/review/report stability data for developmental products (clinical, bulk, pivotal/registration batches).
- Support stability sample testing and data analysis/review; assist with non-stability QC investigations and process improvements.
- Monitor stability chamber room environmental requirements and review documentation (e.g., logbooks).
- Author and maintain Stability Program SOPs.
Qualifications:
- 3+ years’ experience in a pharmaceutical analytical laboratory.
- BS/BA in a scientific discipline or higher.
Skills/Required Tools/Knowledge:
- Statistical analysis tools (e.g., Minitab).
- Stability systems or LIMS systems.
- Analytical testing equipment/procedures (including HPLC and Chromeleon).
- GMP regulations knowledge (as applied to manufacturing analytical laboratory).
- Strong technical writing, attention to detail, and communication skills; strong organizational skills.
- Ability to handle multiple competing priorities; independent, data-driven judgment.
- Advanced computer skills (Word, Excel, PowerPoint) and ability to learn new applications.
Application Instructions:
- Final candidate must complete a drug test and background check prior to employment commencing.