Stability Coordinator

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 65,000 - 95,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC Stability Coordinator for 1st shift (Mon-Fri, 8:00 a.m.–4:30 p.m.) to manage the stability program and data supporting QC activities.

The role involves coordinating with multiple departments, preparing stability samples, and authoring/approving stability protocols. The successful candidate will review analytical data, identify out-of-trend results, and provide data for regulatory submissions, ensuring accuracy and compliance in a fast-paced

Qualifications

• Requires BS/BA in Life Sciences or related field; will substitute relevant experience for education.
• Willing to work 1st shift: Monday–Friday, 8am–4:30pm.

Responsibilities

• Coordinate with other departments to identify and request material for stability studies.
• Authors stability protocols and obtain approvals prior to study initiation.
• Review analytical data and compile in a central database.
• Identify out-of-trend results and support investigations.
• Provide stability data for regulatory submissions and cross-department requests.
• Prepare samples for stability studies (aliquotting, labeling, distribution to chambers).
• Add required testing in LIMS per approved protocol and liaise with outside customers.

Skills

Data analysis

Stability protocols

LIMS

Regulatory compliance

Education

BS/BA in Life Sciences

Tools

LIMS

Job description

We are currently looking to fill a Quality Control (QC) Stability Coordinator with a 1st shift, Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures and tests products for patient safety. The QC 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.

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
• 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
• 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 QC Stability Coordinator position you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm.

Required qualifications

• Requires BS/BA in Life Sciences or related field; will substitute relevant experience for education.

Level is determined based on qualifications relevant to the role.

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, and 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, righ

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, or 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.