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CAMRIS · 2 hours ago

GMP Senior Project Manager

Silver Spring, MD

Full-time

Onsite

Senior Level, Lead/Staff

12+ years exp

CAMRIS is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges. They are seeking a GMP Senior Project Manager to support the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research, overseeing project schedules, client relationships, and program performance to ensure high-quality deliverables.

BiotechnologyInformation Technology

Comp. & Benefits

No H1B

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 re-occurring PBF team meetings between CAMRIS and WRAIR

Hosting and coordinating customer meetings, tours, and calls, as needed

Help 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

Direct leadership and interface with PBF clients as required to optimize PBF productivity and quality of services and advance PBF capabilities in accordance with pOTA mission requirements

Implementation and continuous improvement of manufacturing of PBF Manufacturing procedures, policies, and systems in alignment with or exceeding industry standards

Preparing labor and budget forecasts that anticipate facility, equipment, and workforce needs in coordination with the Vice President of Programs

Standardize processes and workflows to optimize efficiency and productivity. Identify gaps, implement best practices, and develop tools and standards that enhance performance across the entire PBF project portfolio

Develop, maintain, support, and manage project management tools in SmartsheetGov

Assist managers with subcontractor schedule development and maintenance

Optimize and scale the PMO as capacity grows

Support the use of SmartsheetGov for Tier issue tracking and analysis

Build and institutionalize the PBF's Project Management Office (PMO) from the ground up. This includes setting up workflows, roles, and governance structures for optimal functionality and value to the PBF

Support shutdown planning and execution and update capacity utilization metrics

Support mentoring of junior-level Project Management staff

Perform other duties as assigned

Qualification

Biologics development experienceProject management toolsMS Project proficiencyPMP certificationSmartSheet experienceCost analysis experienceOperational excellence familiarityMicrosoft Office familiarityCommunication skillsLeadership experience

Required

BS/BA in business, engineering, life sciences, or a related field and 12 years of biologics development or manufacturing industry experience or an equivalent combination of education and 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