Sr. Project Manager, CDMO and Facilities

CAMRIS•Silver Spring, MD

8d•Onsite

About The Position

We are seeking an experienced Sr. Project Manager, CDMO and Facilities to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. Reporting to the PMO Lead, the Sr. Facilities Project Manager role supports CDMO projects and capital infrastructure implementation at PBF. As a critical technical project manager, the Sr. Facilities PM will oversee PMO systems that track, report on, and administer project scope, cost, and schedule. The role also manages key stakeholder relationships with partner WRAIR contracts across other departments including those supporting shutdown activities, facility improvements, and IT. Twice a year, the role is directly responsible for biannual preventive maintenance shutdown planning, coordination with the WRAIR facilities group, and management of subcontractor schedules. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

Master's degree in engineering, engineering technology, science, operations management, or a closely related discipline, and 10 years of relevant experience, or an equivalent combination of education and credentials.
At least 5 years in a cGMP-regulated pharmaceutical, biopharmaceutical, or government research manufacturing facility.
Demonstrated CDMO industry experience, with knowledge of bioprocess engineering timelines, processes, and quality requirements.
Demonstrated project management experience leading development, manufacturing, facilities, IT or other technical infrastructure projects in a regulated environment.
Experience and familiarization with planning and executing facility shutdowns within active cGMP production environments.
Proficient oral and written external and internal communication.
Proficiency in Smartsheet, Microsoft Project (resource planning, critical path analysis, Gantt development), Excel, Word, PowerPoint, SharePoint, and Teams.
Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.
A REAL ID or U.S. passport is required for WRAIR base access.

Nice To Haves

PMP certification and/or earned value management (EVM) training.
Leadership experience managing cross-functional teams.
Bioprocess development or manufacturing experience.
Technical contractor oversight preferably with IT and OT implementation.
Experience supporting regulatory inspections (FDA, DISA, or equivalent).
Ability to interpret P&IDs, electrical drawings, control schematics, and equipment specifications.
Knowledge of biotech production equipment (bioreactors, autoclaves, chromatography systems, WFI/Pure Steam systems, etc.).
SmartSheet project management best practices and administration.
Experience with cybersecurity ATO requirements and Risk Management Framework (RMF).

Responsibilities

Plan and manage program lifecycle from conception and design through execution.
Track qualification and operational readiness of equipment and systems as necessary.
Solution project challenges multi-disciplinary teams tracking and reporting progress.
Manage project actuals vs. forecast and update status with program leadership.
Drive weekly/biweekly operations, development, QA, and QC scheduling meetings.
Facilitate project team meetings, including scheduling, planning, and tracking.
Work with PBF technical leads and the PBF business development (BD) team in planning and scope generation.
Develop and maintain business relationships with current and prospective customers.
Actively communicate customer and facility constraints.
Evaluate schedule constraints, risk, and feasibility of performing CDMO projects.
Assist managers with subcontractor schedule development and maintenance.
Support shutdown planning and execution and update capacity utilization metrics.
Optimize and scale the Project Management function as capacity grows.
All other duties as requested by the PMO Manager and Program Management.
Lead development and continuous improvement of the PMO framework, including standardized methodologies, tools, templates, reporting, and governance.
Administer, develop, and maintain PMO SmartsheetGov, provision users and update PMO CDMO pricing infrastructure via Smartsheet Control Center.
Enhance site program management revenue, burn rate tracking, CDMO invoicing and project time coding infrastructure.
Stakeholder engagement with partner WRAIR leadership branches and contracts coordinating their support for PBF assets
Plan, coordinate, and execute planned facility shutdowns with minimal disruption to manufacturing schedules and regulatory compliance; develop shutdown plans including scope, resource allocation, risk assessments, and recovery protocols.
Project manage facility equipment and construction projects end-to-end, coordinating with vendors, engineers, and stakeholders, ensuring delivery on time, within scope, and within budget.
Leverage operational and business acumen to track facility capacity utilization and facility expenses including annual subcontracts, overhead expenses and repairs.
Evaluate schedule constraints, risks, and feasibility of performing projects within an active cGMP manufacturing environment.
Manage integration of new or upgraded equipment into facility systems, automation architectures, and environmental monitoring systems.
Coordinate with site IT (WRAIR IMD) enhancing plans for infrastructure development, enhancement, security and upgrades while minimizing plant productivity disruptions.