Project Specialist Quality Control

Regeneron Pharmaceuticals•Rensselaer, IN

6d•$67,400 - $110,000•Onsite

About The Position

We are currently looking to fill a Project Specialist on our Quality Control Technical Resources Team. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing. Regeneron has successfully commercialized numerous products and in this fast-paced environment with a strong pipeline, QC Technical Resources Specialists have the opportunity to develop scientifically and also gain insight into other areas of the business.

Requirements

A BS/BA in Chemistry, Biochemistry, Biology or related field, with 3+ years of relevant experience.
Experience with project management and experience in a GMP setting.
Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

Responsibilities

Project manage validation and qualification activities within the QC TR Chemistry group
Collaborate with internal and external teams to coordinate project management activities
Write and revise assay transfer protocols to external partners and contract labs
Write and revise control test procedures and SOPs
Coordinate and participate in weekly project update meetings
Communicate to management any delay in validation/transfer timelines
Communicate method updates to partners and manage progress of updates
Coordinate post-transfer investigations between contract sites and collaborative partners
Raise discrepancies to management, as needed
Multi-task, prioritize and execute projects independently
Write and review transfer documents such as protocols and reports
Communicate cross-functionally to business units
Develop and drive scientific and/or business-related improvement ideas
Possess effective time management skills, and the drive to meet deadlines