CDMO Project Manager Job US-MD-Silver Spring

We are seeking a CDMO Project Manager to support the Pilot Bio-Production 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 diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

• 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 with 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 BD team in planning and scope generation.
• Develop and maintain business relationships with current and prospective customers.
• Organize and participate in customer and potential customer visits.
• Develop Gantts, including workforce resource assignments for each program.
• 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.

Required

• 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.

Preferred

• Biologics experience in development, manufacturing, or engineering.
• PMP and/or earned value training.
• Experience with cost analysis a plus.
• CDMO project management experience.
• Capital project management experience.
• SmartSheets experience.
• Leadership experience.

CAMRIS International, LLC, offers competitive salaries and comprehensive benefits. 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.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson’s Janssen, is required for this position.

Employment is contingent upon successful completion of a 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.