GMP Project Manager

Camris•Silver Spring, MD

3d•Onsite

About The Position

We are seeking a GMP 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.

Requirements

BS/BA in business, engineering, life sciences, or a related field.
8+ 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

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

Responsibilities

Manage development and manufacturing program schedules to ensure new projects are kicked off according to schedule, in-progress activities are completed on time, and deliverables are sufficiently high quality.
Assemble schedules and performance reports (in SmartSheet, Microsoft PowerPoint, Microsoft Excel, and Microsoft Word), measuring and reporting program performance against the metrics established for the program.
Timely creation and delivery of PBF Monthly Reports summarizing accomplishments, financial variances, and noteworthy challenges to the program.
Lead, coordinate, and participate in recurring PBF team meetings between CAMRIS and WRAIR.
Hosting and coordinating customer meetings, tours, and calls, as needed.
Lead the PMO team and strategically deploy resources to manage and deliver over 20 successful process development and manufacturing projects, ensuring that they meet the defined scope, schedule, cost, and quality criteria.
Build, nurture, and maintain strong relationships with current and prospective clients, both government and private entities. Understand their needs, concerns, and aspirations to deliver solutions that exceed expectations.
Develop Gantts, including workforce resource assignments for each program.
Evaluate schedule constraints, risk, and feasibility of performing projects.
Perform other duties as assigned.