QC Project Lead – Validation & Transfer

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Project Specialist to support QC Technical Resources in managing validation/qualification activities, transfer to partners and labs, and life cycle management of QC assays.

The role emphasizes collaboration across internal and external teams in a fast-paced environment tied to Regeneron's strong pipeline. The ideal candidate holds a BS/BA in a relevant science with 3+ years of experience, including GMP exposure, and can coordinate multiple projects while

Qualifications

• BS/BA in Chemistry, Biochemistry, Biology or related field.
• 3+ years of relevant experience.
• Experience with project management and experience in a GMP setting.

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
• Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

Skills

Project management

GMP experience

Education

BS/BA in Chemistry/Biochemistry/Biology

Tools

Microsoft Office

Job description

Regeneron Pharmaceuticals, Inc. seeks a Project Specialist to support QC Technical Resources in managing validation/qualification activities, transfer to partners and labs, and life cycle management of QC assays.

The role emphasizes collaboration across internal and external teams in a fast-paced environment tied to Regeneron's strong pipeline. The ideal candidate holds a BS/BA in a relevant science with 3+ years of experience, including GMP exposure, and can coordinate multiple projects while