CQV Project Manager

CAMRIS International•Silver Spring, MD

About The Position

Overview We are seeking a CQV Project Manager to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. This multidisciplinary CQV (Commissioning, Qualification, and Validation role will leverage Good Engineering Practices (GEP) and GMP manufacturing background to plan, coordinate and report project scope associated with PBF capabilities expansion and revenue generating technology transfer projects. This dynamic new position manages teams, budgets, schedules, and risks, overseeing the entire lifecycle from planning to execution, focusing on developing protocols, testing, documentation, and regulatory compliance for equipment and processes. 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. Responsibilities 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.

Requirements

BS/BA in business, engineering, life sciences, or a related field.
5+ years of biologics development or manufacturing industry experience.
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.

Nice To Haves

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.
SmartSheet experience.
Leadership experience.

Responsibilities

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.

Benefits

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

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