Scholar Rock Benefits Overview

Leads global commercial Quality Control operations for an outsourced biopharmaceutical manufacturing and testing network. Oversees commercial release and stability testing, specifications, analytical method lifecycle management, external laboratory and CMO performance, investigations, CAPA, regulatory commitments, inspection readiness, and post-approval changes. Partners cross-functionally to support global market supply, compliance, data integrity, and scalable QC systems.

Supports downstream process development, manufacturing science and technology, external manufacturing, and tech transfer for monoclonal antibody products. Responsibilities include purification process development and characterization, CDMO collaboration, process monitoring database ownership, campaign readiness reviews, batch record review, change control implementation, technical presentations, and comprehensive experimental documentation.

Leads drafting, reviewing, and negotiating biotechnology, clinical research, manufacturing, supply chain, commercial, and corporate agreements. Provides legal and compliance guidance across functional teams, supports the contracts management system, delivers training, improves contracting processes, manages multiple projects, and builds cross-functional business relationships within a growing biotechnology legal team.