Quality Control Stability Technician

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 26,000 - 41,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Quality Control Stability Technician to support the Stability Department in Rensselaer, NY. The role operates Monday through Friday, 8:00 am to 4:30 pm, and involves sample handling, LIMS data entry, and maintenance tasks to ensure cGMP compliance.

Key duties include pulling samples at timepoints, subaliquoting materials, receiving samples from sites, shipping to external locations, and performing routine equipment maintenance.

Qualifications

• A high school diploma or GED is required.
• AS/AAS or BA/BS in Life Sciences is strongly preferred.

Responsibilities

• Following procedures to pull stability samples at predetermined timepoints and submit for testing.
• Performing data entry in the Laboratory Information Management System (LIMS) to maintain the inventory of stability samples.
• Subaliquoting bulk drug substance and formulated drug substance samples for incorporation into stability studies.
• Receiving drug product and placebo product samples from internal and external manufacturing sites for incorporation into stability studies.
• Shipping stability samples to external sites for storage and/or testing.
• Performing preventative maintenance activities on laboratory equipment to ensure compliance with established procedures.
• Placing work orders and completing maintenance records in the Computerized Maintenance Management System (CMMS).
• Reviewing stability chamber data and responding appropriately to any change in performance of the chambers or alarms.
• Maintaining inventory of laboratory supplies and organization in the stability areas.
• Assisting Stability Coordinators with labeling of samples and initiation of stability studies.
• Reconciling remaining inventory of completed stability studies in LIMS and disposing of material.

Education

High school diploma or GED

AS/AAS or BA/BS in Life Sciences

Tools

LIMS

CMMS

Job description

We are currently looking to fill a Quality Control Stability Technician position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC Stability Technicians are responsible for supporting the daily operations of the Stability Department in accordance with Standard Operating Procedures (SOPs) and cGMP regulations.

Location:

Rensselaer, New York, United States

Work model:

Monday - Friday 8am - 4:30pm

Discover Your Role:

• Following procedures to pull stability samples at predetermined timepoints and submit for testing
• Performing data entry in the Laboratory Information Management System (LIMS) to maintain the inventory of stability samples
• Subaliquoting bulk drug substance and formulated drug substance samples for incorporation into stability studies
• Receiving drug product and placebo product samples from internal and external manufacturing sites for incorporation into stability studies
• Shipping stability samples to external sites for storage and/or testing
• Performing preventative maintenance activities on laboratory equipment to ensure compliance with established procedures
• Placing work orders and completing maintenance records in the Computerized Maintenance Management System (CMMS)
• Reviewing stability chamber data and responding appropriately to any change in performance of the chambers or alarms
• Maintaining inventory of laboratory supplies and organization in the stability areas
• Assisting Stability Coordinators with labeling of samples and initiation of stability studies
• Reconciling remaining inventory of completed stability studies in LIMS and disposing of material

You can effectively communicate issues and ideas with peers and with management. You have a strong ability to achieve thoroughness and accuracy when performing repetitive tasks. You have the capability to adjust to shifting priorities, manage multiple tasks and meet deadlines. You have the capability to organize and maintain data or information.

This role requires:

• A high school diploma or GED required.
• AS/AAS or BA/BS in Life Sciences, or related field, is strongly preferred.
• Level is determined based on qualifications relevant to the role.

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.

Salary Range (hourly) $18.94 - $29.62

Equal Opportunity Employer Statement:

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 therea), 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.

Equal Opportunity Employer Statement (extended):

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 therea), 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.

Company Overview:

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.

Social Responsibility and Culture:

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!