PROJECTS
Delivering Results Across Biotech Manufacturing and Regulated Facilities
Arc Bio Consulting supports biotechnology and life sciences organizations through complex capital projects, facility expansions, manufacturing initiatives, and operational readiness programs. Recent project experience includes GMP manufacturing expansions, facility renovations, commissioning & qualification support, and design gap assessments & oversight in highly regulated environments.
ELEVATE BIO
Cell Therapy GMP Manufacturing Expansion
Location: Waltham, Massachusetts
Project Type: Cell Therapy GMP Manufacturing Expansion
Role: Owner's Representative Project Management (OPM)
Completion: 2025
Project Overview
Managed the project from final design through construction, CQV, and operational readiness, delivering a 17,000-square-foot expansion that transformed existing space into a new GMP manufacturing area. The completed facility included three Grade B cell therapy suites and Grade C production support capabilities. A key challenge was executing the full buildout while maintaining uninterrupted operations within adjacent active GMP manufacturing areas.
Project Leadership
As the OPM for this project performed the following:
- Ultimate oversite of the Construction Manager (CM) and the Architect/Engineer
- Managed the program schedule, design changes, budget, and reporting
- Coordinated site-wide communications of construction activities, landlord approvals and Tenant Improvement requisition process
- Supported site quality alignment, owned the change management process, coordinated regulatory requirement gap assessments
- Managed the Building Commissioning and CQV procurement, onboarding and execution.
PROMED
Medical Device & Combination Product Manufacturing Facility Buildout
Location: Plymouth, Minnesota
Project Type: Medical Device and Drug Combination Product Manufacturing Brownfield Buildout
Role: Owner's Representative Project Management (OPM)
Completion: 2026
Project Overview
Supported the renovation and buildout of an existing facility to support GMP contract manufacturing or medical device and drug combination products. The renovation project was to create four Grade C manufacturing suites along with associated MALs, PALs, warehousing areas, material sampling capabilities, and future expansion capacity. Oversight was provided throughout final design and construction to ensure the facility met both operational requirements and qualification objectives.
Project Leadership
As the OPM for this project performed the following:
- Gap assessed design for regulatory compliance and implemented remediations to ensure audit readiness
- Managed redesign of segregated Building Management System (BMS) and Critical Monitoring System (CMS)
- Redesigned facility pressurization scheme to align with client and regulatory requirements.
- Coordinated ETOP development with subcontractors on behalf of GC to ensure CQV efficiency
- Coordinated final drawing as-builts and GMP drawing set development
Experience Across Leading Biotech Organizations
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