IT Hardware Manager

Job ID: req2661
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting the Director, Administration & Operations, the Manager, IT Systems will:

• Work with Director, Administration & Operations, and key staff to further the department's mission by participating in strategy and direction setting, identifying, and prioritizing areas for improvement, assisting project teams with scope definition, and encouraging best practice change management
• Exercise initiative, ingenuity, independent analysis, and judgment in solving complex and difficult administrative, managerial, and technical problems
• Execute department plans; organize, direct, and coordinate activities to ensure consistency across the IT Department with an emphasis on continuing to standardize and improve core service and delivery, while managing organizational effectiveness, compliance/risk, and resources
• Direct IT staff working on IT projects and enforces project management disciplines
• Work collaboratively to coordinate system availability, performance management, and capacity planning issues; assure timely, accurate and prompt turnaround of work orders/requests
• Assist in preparing, monitoring, and administering annual budget for the IT department, including staffing, equipment, and supplies
• Coach, manage, and develop employees by establishing clear goals, expectations, and strategies for employee performance
• Demonstrate leadership in the implementation, integration, and support of a wide range of scientific and business applications and be able to manage the successful delivery of simultaneous IT initiatives, strategies and projects of varying complexity and priority
• E xpand on an existing IT strategy and system infrastructure at the VPP
• M anage the upkeep of a validated electronic document control system (LiveLink), a maintenance and calibration system (RAM), a training system (Plateau), enterprise resource planning system, (X3) and QA monitoring system (Trackwise); the installation and maintenance of LIMS and MODA environmental monitoring systems; oversee other hardware and software installations, including standalone QC systems; and the administration of a range of computer technologies from PC desktop support to network integration of these complex data systems
• Manage the administration of the VPP's internal and external communication systems, including remote access capabilities and high-speed data links between locations
• Partner with the QA computer validation group, assisting in computer validation, life-cycle development, and change management; TCP/IP network administration and security practices as well as disaster recovery planning
• M anage an experienced technical support group
• Interact effectively with multiple disciplines within the organization and the ISP
• Provide timely, professional resource planning and budgeting, continuously demonstrating fiscal responsibility

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA), (Qualifying four (4) years' experience in IT operations and management may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum four (4) years IT experience in a biotech or pharma environment
  
• Two years (2) years experience in a lead or supervisory position
• Experience interfacing with high level research and IT personnel on a variety of demanding projects
• Must have experience in the deployment of applications within an FDA regulated (GXP) environment
• D emonstrated understanding of and ability to manage varied and complex systems
• Experience in the use of commercially available electronic document control systems, experience in the deployment of web-based and client-server architectures
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Ability to design and interface divergent IT systems resulting in the transparent communications and operations between them
• Demonstrated initiative and problem-solving skills
• Experience managing and motivating multiple, cross-functional teams through direct or matrix reporting structures
• E xperience with computer validations, defining user and functional requirements, designing test scripts, and managing change control
• Experience on medium to large scale automation projects
• One (1) year of experience managing a medium to large scale computer facility

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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