Quality Control Specialist (Technical Resources)
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 15, 2023
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Pharm Country, Best Places to Work
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.
- 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.
Salary Range (annually)$63,500.00 - $103,700.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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