The Senior Manager, Data Integrity will lead the development and implementation of IT-driven data governance strategies, ensuring the integrity and regulatory compliance of all digital data across the organization’s systems. This role will be responsible for implementing and maintaining cGMP applications throughout its SDLC. This role is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.

The Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provide updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model.

Develop new processes as needed for the production of plasma-derived therapies; Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes.

The Project Manager will manage projects by analyzing information, developing and tracking project plans, providing expertise to resolve project difficulties and directing resources.