Quality Control Specialist (Technical Resources)

Regeneron is looking for a QC Technical Resources Specialist to work Monday-Friday, 8am-4:30pm. This role utilizes and applies scientific knowledge and techniques to perform and review assay optimization, transfer, validation and investigation for QC group for in-coming component and secondary packaging. Provides guidance, technical advice, and supervision for release, in-process testing, and assay development as a subject matter expert (SME).

As a QC Technical Resources Specialist, a typical day may include the following:

• Develops and validates methods for in-coming components and secondary packaging both compendial and non-compendial.
• Supports investigations from a technical perspective for methods.
• Engages with Combination product teams to bring methods to QC Commercial before process validation, evaluates and determines the appropriate methods to bring to QC Commercial.
• Analyzes and Monitors day-to-day method performance in QC lab, including determining if problem resolution requires appropriate subject matter expert to help with any method-related issues
• Communicates method updates to partners/contract labs and tracks progress of updates.
• Participates in and coordinates post-transfer investigations between contract sites and collaborative partners.
• Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time.
• Escalates issues to management, as needed.
• Continuously drives to improve processes for improved performance.
• Supports investigational identification analysis.
• Performs and/or coordinates assay qualification for the QC Group.
• Drafts new test procedures and assays for QC Group.
• Authors and/or coordinates technical document preparation (Analytical Development Reports, Assay Validation Reports).
• Participates in training programs for QC personnel.

This role might be for if you have:

• Ability to quickly learn and adapt.
• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
• Skills at gathering and organizing information.
• Ability to follow directions and perform well-defined tasks.
• Effective time management skills.
• Excellent written and oral communication skills.
• Ability to develop strategy and create metrics to measure effectiveness of strategy.
• Ability to identify and effectively communicate risks.

To be considered for a QC Technical Resources Specialist position you must be willing and able to work Monday-Friday, 8am-4:30pm. This role requires a BS/BA in a Life Sciences field. For specific levels please see below. Associate Specialist: BS/BA in a Life Sciences field or equivalent combination of education and experience. Specialist: Requires BS/BA in a Life Sciences field and 2 years of relevant experience in a cGMP environment or equilvant combination of education and experience. Experience with in-coming component and functional testing is desired.

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$63,500.00 - $103,700.00