Sr. Project Manager, CDMO and Facilities

Job Description

Overview:

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.

Responsibilities:

General CDMO Project Management Leadership

• 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.

PMO & QA Infrastructure

• 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.

Shutdown Planning, IT Infrastructure and Facility Project Management

• 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.

Qualifications

Required

• 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.

Preferred

• 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).

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Rarely conduct light work that includes moving objects up to 20 pounds.
• Rarely 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.
• Rarely bend, reach, or twist repeatedly.
• Rarely kneel, squat, or stoop.
• Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Rarely ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
• Rarely move self in different positions to accomplish tasks in various environments including tight and confined spaces.
• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Rarely work in low-temperature environments.
• Rarely work in high-temperature environments.
• Occasionally work in outdoor elements, such as precipitation and wind.
• Rarely work in noisy environments.
• Occasionally work in environments where no adverse environmental conditions are expected.

PPE and Chemical Requirements

• Occasionally wear PPE including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Rarely wear a lab coat.
• Rarely wear earplugs/muffs.
• Occasionally wear a clean room uniform.
• Rarely wear a respirator, such as disposable dust/surgical mask, disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
• Rarely come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust and powders, etc.

Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

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.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.