QC Project Lead: Validation, Transfers & Assays

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals is looking for a Project Specialist to join the Quality Control Technical Resources team in the US. You will support project management of validation and qualification activities, transfers to partner and contract sites, and lifecycle management of QC assays.

Collaborate with internal and external teams, write and revise transfer protocols and SOPs, and coordinate weekly project updates.

Qualifications

• BS/BA in Chemistry, Biochemistry, Biology or related field.
• 3+ years of relevant experience.
• Experience with project management and 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 delays in validation or transfer timelines to management
• Update partners on method changes and track progress
• Coordinate post-transfer investigations between contract sites and collaborators
• 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 scientific or business-related improvement ideas
• Demonstrate time management to meet deadlines
• Proficient in Microsoft Office: Word, Excel, PowerPoint

Skills

Project management

Cross-functional collaboration

Time management

Education

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

Tools

Microsoft Office

Job description

Regeneron Pharmaceuticals is looking for a Project Specialist to join the Quality Control Technical Resources team in the US. You will support project management of validation and qualification activities, transfers to partner and contract sites, and lifecycle management of QC assays.

Collaborate with internal and external teams, write and revise transfer protocols and SOPs, and coordinate weekly project updates.