Stability Coordinator

Regeneron Pharmaceuticals•Rensselaer, NY

2d•$21 - $34•Onsite

About The Position

Stability Coordinator At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Stability Coordinator to join our Quality Control team. In this role, you will help ensure the ongoing safety, quality, and regulatory compliance of Regeneron's medicines by administering the company's stability program and managing the data generated in support of it, while collaborating with Quality Assurance, Regulatory Affairs, Manufacturing, and outside testing partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Bachelor’s degree in Life Sciences or a related field.
Strong attention to detail and comfort working with data in a regulated environment.
Ability to work effectively both independently and as part of a cross-functional team.
Clear written and verbal communication skills, particularly for authoring protocols and reporting data.

Nice To Haves

Prior experience in a stability program, quality control, or analytical testing environment.
Familiarity with Good Manufacturing Practice (GMP) or other regulated laboratory settings.
Experience with database systems used to compile and track scientific data.
Exposure to supporting regulatory submissions or interacting with regulatory agencies.

Responsibilities

Coordinate with other departments to identify materials that need to be placed on stability.
Author stability protocols and secure the necessary approvals before each study begins.
Review analytical data and compile it into a central database to support ongoing studies.
Supply stability data needed for the submission of regulatory documents.
Share stability data with other departments upon request.
Maintain the stability chamber inventory and monitor chamber performance.
Remove samples from chambers according to protocol pull schedules and submit them to the appropriate testing group.
Prepare samples for stability studies, including aliquotting, labeling, and distributing them to the correct chamber.
Comply with all pertinent regulatory agency requirements, including Good Manufacturing Practice (GMP) standards.