GMP Senior Project Manager

Overview

We are seeking a GMP Senior Project Manager to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

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.

• Solution project challenges with multi‑disciplinary teams tracking and reporting metrics.
• Manage project actuals vs. forecast and update status with program leadership.
• Facilitate project team meetings, including scheduling, planning, and tracking.
• Experience scheduling and executing GMP equipment design, testing and qualification.
• Project planning and project lifecycle management from conception to completion.
• Track qualification and operational readiness of equipment and systems, as necessary.
• Leverage dependency matrices, diagrams, and gap assessments to define project scope.
• Communicate and coordinate with PBF stakeholders to define scope and budget.
• Grow and maintain relationships with WRAIR staff, customers, and vendors.
• Organize and participate in customer and potential customer visits.
• Manage project submittals, change control processes and project management artifacts.
• Actively communicate customer project 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.
• Perform other duties as assigned.

• BS/BA in business, engineering, life sciences, or a related field and 10 years of biologics development or manufacturing industry experience, or an equivalent combination of education and credentials.
• MS Project proficiency, including resource planning.
• MS Excel, MS Word, MS SharePoint, and MS Teams familiarity.
• Familiarity with implementing operational excellence.
• Excellent written and verbal communication skills.
• 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.

• PMP and/or earned value training.
• Knowledge of GMP, EU, FDA, ISPE guidance as it applies to multi‑modal pharmaceutical manufacturing.
• Biologics experience in development, manufacturing, or engineering.
• Experience with cost analysis and finance.
• CDMO project management experience.
• Capital project management experience.
• Smart Sheet experience.
• Leadership experience.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Occasionally push or pull less than 25 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Occasionally kneel, squat, or stoop.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to…