Quality Control Stability Coordinator
Regeneron is currently looking for a Stability Coordinator for our Quality Control Team with a 1st shift, Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures and tests products for patient safety. The Lead Stability Coordinator will be performing a variety of activities to administer the stability program and manage data generated in support of Regeneron’s quality program. They will perform all tasks in support of formal stability studies for Regeneron’s clinical and commercial products to ensure their safety, efficacy, and timely delivery for our patients.
As a Stability Coordinator, a typical day might include the following:
- Coordinates with other departments to identify and request material to be put on stability
- Authors stability protocols and obtains necessary approvals prior to study initiation
- Performs review of analytical data and compiles into a central database
- Identifies out of trend or atypical results and supports ongoing investigations
- Provides stability data necessary for the submission of various regulatory documents
- Reviews stability sections of regulatory submission documents
- Provides stability data to other departments upon request
- Prepares samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber)
- Adds required testing in LIMS per approved stability protocol
- Interacts with outside customers or functional peer groups
- May be responsible for maintaining a specific project
- Complies with all pertinent regulatory agency requirements
- Participates in required training activities
- Authors stability trend reports, decay rate reports and interim reports and routes for approvals in a timely manner
- Ships samples to contractor facilities for testing as required
This role might be for you if:
- Enjoys dynamic day to day work
- Can handle competing priorities
- Can participate in continuous idea projects in addition to routine work
- Are a critical problem solver and can apply fundamental troubleshooting methods
- Enjoys data gathering and data trending to support Regeneron’s products and investigations
- Willing to wear appropriate PPE to get the job done safely when necessary
- Ability to push and pull weights up to 50 lbs
To be considered for the Stability Coordinator you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. You must have the following: Requires BS/BA in Life Sciences or related field; Or equivalent combination of experience and education.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.