Stability Coordinator
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. When & where: Shift Requirements: Monday through Friday 1st shift Location: Rensselaer, New York What you'll do: 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. The environment and physical rhythms of this role: This role might be for you if...
You stay organized and can manage multiple ongoing studies and pull schedules at once. You take ownership of your work and follow through on commitments without needing close oversight. You communicate clearly and comfortably with colleagues across different departments and functions.
You care about precision and consistency, since small errors in stability data can have significant downstream effects. Let's find out if we're a fit: Must-haves: 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
Preferred
- 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.
- Student Loan Paydown program & Tuition Reimbursement Family Care Benefits Inclusion, Culture and Well-Being programs (including physical & mental health) Does this sound like you?
- Apply now to take your first step towards living the Regeneron Way!
- We are committed to building a workplace with an inclusive culture.
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status
- any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
- Where necessary, we disclose salary ranges for roles in all countries in which we operate.
- The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.
- In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
- Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off
- family support benefits.
- For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ .
- For other locations, additional information will be provided during the recruitment process.
- If you have any questions, please speak with your recruiter.
- Please be advised that at Regeneron, we believe we do our best work when we are together.
- For that reason, many roles are required to be performed on‑site.
- Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
- As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based.
- The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
- For jobs in Canada: this posting is for an existing position.
- Salary Range (hourly) $21.49 - $33.61