Stability Coordinator

Job Summary

This position is responsible for planning, coordination, oversight of the execution and completion of the Stability Program for both Aquestive owned products as well as non-Aquestive owned products. This includes setting testing strategy, initiating and managing all stability studies.

Responsibilities

• Subject Matter Expert on ICH guidelines.
• Perform statistical analysis, tracking and trending of all data points associated with stability studies.
• Create, maintain and manage changes to stability set down and pull schedule, ensuring compliance with internal SOPs and ICH standards.
• Manage stability scheduling tools and ensure timely communication between all internal and/or external parties to ensure on time testing, data reporting and report generation.
• Establish requirements/general strategy for stability batches and communicate to Production and other necessary parties, ensuring annual commitments are met.
• Author stability protocols per applicable annual commitments and ICH guidelines, agency filings and business rules.
• Author all stability summary reports in a timely manner, ensuring all data is statistically analyzed, and any trends noted throughout the stability program are appropriately addressed.
• Perform data entry for stability control charts; identify trends (including OOS and ATR) and lead investigations real-time as necessary.
• Create data packages to fulfill Statements of Work with external business contracts, ensuring on-time delivery.
• Draft Statements of Work related to stability for external business contracts, coordinating with both internal and external parties through to execution.
• Author stability summary requirements for inclusion in Annual Product Quality Review reports for all products.
• Work closely with Analytical R&D and CMC Development to author, review and report stability data for developmental products, including clinical batches, bulk stability and pivotal/registration batches.
• Aid in stability sample testing or data analysis/review if necessary.
• Aid in data analysis for non-stability complex QC investigations and/or process improvements.
• Monitor and maintain the stability chamber room for adherence to established environmental requirements and audit/review stability chamber documentation (i.e., logbooks).
• Authors and maintains all Standard Operating Procedures (SOPs) for the Stability Program.

Qualifications

• 3+ years of experience in a pharmaceutical analytical laboratory.
• BS/BA degree in a scientific discipline or higher required.
• Experience utilizing statistical analysis tools required (i.e., Minitab).
• Experience with Stability systems or LIMS systems.
• Proficient knowledge of analytical testing equipment and procedures required, including HPLC and Chromeleon.
• Proficient in GMP regulations, as they apply to manufacturing analytical laboratory.
• Strong attention to detail and ability to handle multiple projects with competing priorities.
• Excellent technical writing skills.
• Excellent oral and written communication skills with strong interpersonal skills.
• Highly motivated and self-directed with strong organizational skills.
• Able to exercise independent intellectual judgment using data driven decision making.
• Highly proficient and advanced in computer use (Word, Excel, PowerPoint, etc.) with ability to learn and master new computer applications.