Stability Program Lead — Data-Driven QA for Pharma

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

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.