Quality Control Project Specialist - Validation & Transfers

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); Vor Ort; USD 67.000 - 110.000; Vollzeit

Benefits dieser Stelle

Annual bonuses

Equity awards

Pension benefits

401(k) match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Zusammenfassung

Regeneron Pharmaceuticals, Inc in Rensselaer, NY is seeking a Project Specialist for the Quality Control Technical Resources team. You will manage validation and qualification activities and coordinate transfers to partner labs, while maintaining lifecycle management of QC assays.

The role offers exposure to multiple teams and growth in a fast-paced biotech environment. The position requires a BS/BA in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience and GMP

Qualifikationen

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

Aufgaben

• 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)

Kenntnisse

Project management

GMP experience

Quality control

Cross-functional collaboration

Documentation writing

Ausbildung

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

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

Regeneron Pharmaceuticals, Inc in Rensselaer, NY is seeking a Project Specialist for the Quality Control Technical Resources team. You will manage validation and qualification activities and coordinate transfers to partner labs, while maintaining lifecycle management of QC assays.

The role offers exposure to multiple teams and growth in a fast-paced biotech environment. The position requires a BS/BA in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience and GMP