Stability Coordinator

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 34,000 - 54,000; Full time

Benefits offered by this job

Annual bonuses

Health benefits

401(k) company match

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a QC Stability Coordinator for 1st shift (8am–4:30pm). You will oversee the stability program, manage data, and support stability studies for clinical and commercial products to ensure safety and timely delivery.

The role involves coordinating stability materials, preparing samples, and ensuring regulatory compliance through data generation and reporting. A BS/BA in Life Sciences is required; experience may substitute education.

Qualifications

• Willingness to work 1st shift, Mon-Fri 8am-4:30pm.
• BS/BA in Life Sciences or related field; relevant experience may substitute education.

Responsibilities

• Coordinate with departments to identify materials for stability.
• Author stability protocols and obtain approvals.
• Review analytical data and compile in central database.
• Identify out-of-trend results and support investigations.
• Provide stability data for regulatory submissions.
• Prepare samples for stability studies and run testing in LIMS.
• Interact with customers and peer groups while adhering to regulatory requirements.

Skills

Data gathering

Data trending

Troubleshooting

Stability data

Education

BS/BA in Life Sciences or related field

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 / Responsibilities

• 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

Ideal Candidate

• 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

Qualifications

• Must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm.
• 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.

Diversity & Inclusion

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.

Background Checks

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.

Salary Range

Salary Range (hourly) $24.76 - $38.70

For jobs in Canada: this posting is for an existing position.

Benefits

• 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.

About Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.