Stability Coordinator

Regeneron Pharmaceuticals; Rensselaer (IN); Sur place; USD 34 000 - 54 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals is seeking a QC Stability Coordinator for 1st shift (Mon-Fri, 8:00 am–4:30 pm) to administer the stability program and manage data supporting Regeneron’s quality program. Responsibilities include preparing samples, authoring stability protocols, reviewing analytical data, and generating stability reports.

A BS/BA in Life Sciences or related field is required; related experience may substitute education.

Qualifications

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

Responsabilités

• Coordinate stability studies by preparing samples and organizing materials.
• Author stability protocols and obtain approvals prior to study initiation.
• Review analytical data and compile results in a central database.
• Identify out-of-trend results and support investigations.
• Provide stability data for regulatory submissions and cross-functional requests.
• Prepare samples for stability studies and manage labeling and distribution to chambers.
• Record and test in LIMS as per protocol; ensure compliance with regulations.

Formation

BS/BA in Life Sciences or related field

Description du poste

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.

As QC 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
• 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.

You must have the following: 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.

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.

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.

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.

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)

$24.76 - $38.70