MARKETS
Biotechnology
SERVICES
Biologics
Facilities & Utilities
Project Management
Global biotechnology company in need of comprehensive program management support for the design, construction, and qualification of a CGMP manufacturing facility to enable spray-dried biologics production. The project required coordination of facility design, equipment and utilities integration, vendor management, and quality systems implementation to support phase-appropriate GMP clinical manufacturing. This program management support was essential to ensure regulatory compliance, streamline project execution, and establish a scalable Project Management Office framework for ongoing biologics manufacturing operations.
CHALLENGE
SOLUTION
RESULTS
- Provide program management support for the design, construction, and qualification of a new CGMP manufacturing area for in house of clinical supplies using a proprietary aspetic spray-dried processes.
- Collaborate with the construction partner to design and retrofit the current facility and work within facility, equipment, and utilities for phase-appropriate GMP clinical manufacturing.
- Updated the current QMS to include the required phase-appropriate procedures and documentation to enable the clinical manufacturing operations.
- Identified that the Client group lacked formal processes for project management of vendors, including the construction partner.
- Conducted stakeholder interviews and engaged vendor project managers to clarify roles, responsibilities (RACI), and deliverables.
- Created a working group within the Client organization across multiple locations within the US to execute against the project plan, identifying key stakeholders and establishing communication and process structures.
- Developed a project management toolkit utilizing best-in-class templates for budget monitoring and project scheduling to standardize and streamline vendor and project oversight.
- Successfully built and qualified the GMP manufacturing site for spray-dried biologic production, and completed process equipment transfer and qualification.
- Design and implemented a Project Management Office (PMO) program for the Client specifically tailored for managing, ensuring improved coordination and oversight.
- Established a scalable project management framework supporting future partner collaborations within the Client’s organization.