Stability Project Manager (Scientist)

at  Amaris

Job description

JOB DESCRIPTION:

We are seeking a Stability Project Manager to play a crucial role in the Analytical Development department. The team focuses on achieving a comprehensive scientific understanding of the stability behavior of Drug Substance (DS) and Drug Product (DP) for small molecules and new modalities. Responsibilities include designing, performing, and interpreting customized stability studies, as well as (non-)clinical introduction and production/characterization support of the DS and DP from phase I through to registration.
Your Responsibilities: As the Stability Project Manager, you will be assigned to various development projects, managing all related CRS aspects and serving as the point person on stability and release issues for the assigned development projects. Your main responsibilities will include:
Designing and coordinating experiments to assess the chemical and physical stability of new products
Working closely with internal and external laboratories to ensure successful execution
Providing insight into long-term drug stability using predictive models and traditional stability tests
Performing data trend analysis
Representing the group on cross-functional analytical teams
Communicating and reporting stability results
Coordinating global projects
Managing analytical investigations and discrepancies
Ensuring compliance with relevant regulations, GMP, and safety

Please refer the Job description for details