Quality Control Technical Resources Specialist

Location
Rensselaer, NY, United States
Posted
Sep 25, 2020
Ref
21374BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Quality Control Technical Resources Specialist with a Monday-Friday, 8am-4:30pm schedule. This position is part of the Quality Control Technical Resources Bioassay Team. Regeneron has successfully commercialized numerous products. This position will be responsible for life cycle management of cell-based and binding assays utilized in Quality Control testing. In this fast-paced environment with a strong pipeline, Quality Control Technical Resources Specialists have the opportunity to develop scientifically and also gain insight into other areas of the business.

As a Quality Control Technical Resources Specialist, a typical day might include the following:
• Work with Analytical Sciences to ensure method readiness to bring to QC commercial before process validation.
• Monitor day-to-day method performance in QC Commercial lab and identify appropriate. subject matter expert to help with any method-related issues.
• Communicate to management any delay in validation/transfer timelines.
• Communicate method updates to partners and manage progress of updates.
• Coordinate and review method performance reports and quality metrics.
• Implement multi-site method harmonization and reviews of method performance.
• Coordinate post-transfer investigations between contract sites and collaborative partners.
• Track team activities and timelines to ensure that the deliverables within the project plans are met and on time.
• Raise discrepancies to management, as needed.
• Act as subject matter expert and provide technical support, as needed.

This role might be for you if you:
• Enjoy working in a fast-paced environment.
• Have development experience in cell-based potency assays or ELISA.
• Are able to multi-task, prioritize and execute projects independently and communicate cross-functionally to business units.
• Have experience with troubleshooting potency assays for testing in a GMP environment.
• Can take on new and sometimes ambiguous challenges and learn quickly.
• Are able to write large technical reports and lead projects.
• Develop and drive scientific and/or business-related improvement ideas.
• Possess effective time management skills, and the drive to meet deadlines.
• Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint) and Softmax.
• Understand working with statistical software such as JMP.

To be considered for the Quality Control Technical Resources Specialist position you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Biology, Biochemistry, Cell Biology or related field; Cell Biology, Biology or Biochemistry preferred, and 2+ years of related experience. Experience with binding assays, cell- based potency assays and ELISA testing preferred. Experience in a GMP setting is required. 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.

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