QC Project Specialist – 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 for the Quality Control Technical Resources Team in Rensselaer, NY. You will manage validation/qualification activities, coordinate with internal/external teams, and write/ revise transfer protocols and SOPs.

You will also lead weekly project updates, communicate delays, and drive improvements while leveraging MS Office tools for documentation and reporting.

Qualifications

• BS/BA in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience.
• Experience with project management and GMP settings.
• Ability to coordinate cross-functional teams and document transfer activities.

Responsibilities

• Project manage validation and qualification activities within the QC TR Chemistry group.
• Coordinate project management activities with internal and external teams.
• 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 delays in validation/transfer timelines to management.
• Coordinate post-transfer investigations between contract sites and partners.
• Multi-task, prioritize and execute projects independently.
• Develop and drive scientific or business improvement ideas.
• Work with Microsoft Office tools to document and present data.

Skills

Project management

Cross-functional collaboration

Technical writing

Communication

Time management

Education

BS/BA in Chemistry, Biochemistry, Biology or related field

Tools

Microsoft Office

Job description

Regeneron Pharmaceuticals, Inc. seeks a Project Specialist for the Quality Control Technical Resources Team in Rensselaer, NY. You will manage validation/qualification activities, coordinate with internal/external teams, and write/ revise transfer protocols and SOPs.

You will also lead weekly project updates, communicate delays, and drive improvements while leveraging MS Office tools for documentation and reporting.