Senior Review Scientist, Biologics Standards

BioSpace; Indiana; Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Company-paid time off

Healthcare options

Retirement savings

Zusammenfassung

USP in Indiana seeks a Scientist IV (Reviewer) to provide technical and quality reviews of documents for biological products including peptides, vaccines, and complex biologics. The role supports the Reference Standards program and stability testing, ensuring accuracy, clarity, and compliance across documentation.

The incumbent will work with cross-functional teams, develop SOPs, and review analytical data to confirm RS suitability, contributing to continuous process improvements while

Qualifikationen

• Ph.D. in Biochemistry/Biological Science/Pharmaceutical Science with 3–5 years of commensurate industrial experience, or Master's with 8–10 years of commensurate industrial experience.

Aufgaben

• Performs technical and quality reviews of documents to ensure a high level of document quality and compliance before QA review.
• Manages and tracks efforts for continuous process improvements.
• Develops and reviews SOPs, Operation Manuals, and training documents.
• Assists in investigations of quality related issues including root cause analysis and action implementation tracking.
• Collaborates with internal stakeholders to develop new and innovative standards for analytical analysis of biological products.
• Communicates with cross functional USP departments regarding assigned projects.
• Supports RS Stability program operations and RS catalog inventory.
• Reviews RS testing history and drafts CSU test protocols for labs.

Kenntnisse

Technical writing

Analytical reasoning

Oral communication

Team collaboration

Ausbildung

Ph.D. in Biochemistry/Biological Science/Pharmaceutical Science

Master’s degree in Biochemistry/Biological Science/Pharmaceutical Science

Tools

UPLC/HPLC

LC-MS

CD

FTIR

DSC

SEC‑MALS

CE‑SDS

ELISA

SPR

ddPCR/qPCR

Jobbeschreibung

USP in Indiana seeks a Scientist IV (Reviewer) to provide technical and quality reviews of documents for biological products including peptides, vaccines, and complex biologics. The role supports the Reference Standards program and stability testing, ensuring accuracy, clarity, and compliance across documentation.

The incumbent will work with cross-functional teams, develop SOPs, and review analytical data to confirm RS suitability, contributing to continuous process improvements while