Sr. Quality Control Analyst- Clinical Bioassay

Rensselaer, New York, United States of America
Jul 19, 2021
Required Education
Bachelors Degree
Position Type
Full time
Regeneron is currently looking for a Quality Control (QC) Analyst position on our QC Analytical Science (AS) Clinical Bioassay Team. This position is a 1st shift, Monday-Friday, 8 AM - 4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC Analysts at Regeneron perform the critical testing necessary to ensure the consistency and quality of both clinical and commercial products. The ideal candidate for this position would have experience with binding or bioassays used for potency testing in a GMP setting.

As a Quality Control Analyst, a typical day might include the following:
• Perform QC testing on raw materials, in-process, product, stability, and/or research samples
• Perform associated support activities including maintaining laboratory supplies, preparing/aliquoting reagents and performing equipment maintenance
• Completes test records and documents test results
• Reviews test results to ensure compliance with standards; identifies/investigates any quality anomalies
• Gather and/or summarize data for investigations
• Review logbooks, notebooks or testing data
• Compliance with all applicable SOPs as well as site and pertinent regulatory agency requirements
• Participates in required training activities
• Writes and revises control test procedures and SOPs
• Interacts with outside customers or functional peer groups
• May be responsible for maintaining specific projects
• May assist in qualification and validation of methods
• May be involved in establishing the transfer of methodology from R&D
• May devise or develop new analytical methods and techniques

This role might be for you if you:
• Have experience with potency assays or mammalian cell culture
• You enjoy project oriented work with a career goal of becoming a subject matter expert
• You thrive in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients
• Maintain integrity and honesty at all times
• Enjoy working independently and collaboratively within a team
• Continuously drive to improve processes for improved performance
• Have a basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
• Have excellent written and verbal communication skills
• Can gather and evaluate data

To be considered for the Quality Control Analyst on our Analytical Sciences Clinical Bioassay team, you must be willing and able to work Monday-Friday, 8 AM - 4:30 PM. For the various levels you must have the following:
Sr. QC Analyst I: BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience
Sr. QC Analyst II: BS/BA in Life Sciences, or related field, and 6+ years of experience; or an equivalent combination of education and experience
Experience with mammalian cell culture practices, bioassay and/or binding assay testing, and working in a GMP environment is preferred. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! 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!

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, 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. Please contact us to discuss any accommodations you think you may need.