Stability Coordinator

Aquestive Therapeutics; Portage (IN); On-site; USD 75,000 - 95,000; Full time

Job summary

Aquestive Therapeutics in Portage, Indiana is seeking a Stability Program expert to oversee execution and completion of stability studies for both owned and non-owned products. The role demands extensive experience in pharmaceutical analytics and strong knowledge of ICH guidelines.

Candidates must have a BS/BA in a scientific field, proficiency with statistical tools like Minitab, and adeptness in GMP regulations. The position emphasizes strong organizational and communication skills and offers a collaborative environment for professionals dedicated to maintaining high standards in product quality.

Qualifications

• 3+ years of experience in a pharmaceutical analytical laboratory.
• Proficient knowledge of analytical testing equipment and procedures.
• Strong attention to detail and ability to handle multiple projects.

Responsibilities

• Plan and coordinate the execution of the Stability Program.
• Perform statistical analysis for stability studies.
• Manage stability scheduling and communicate with parties involved.
• Author stability protocols and summary reports.
• Monitor adherence to stability chamber room requirements.

Skills

Statistical analysis tools

Analytical testing equipment

GMP regulations

Technical writing

Computer proficiency (Word, Excel, PowerPoint)

Education

BS/BA degree in a scientific discipline

Tools

Minitab

HPLC

Chromeleon

Job description

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.
• Creates, maintain and manage changes to stability set down and pull schedule, ensuring compliance with internal SOPs and ICH standards.
• Manages stability scheduling tools and ensures 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.
• A 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.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.