cGMP Facility Director - Frederick National Laboratory for Cancer Research

cGMP Facility Director

Job ID: req4051
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

• Supervises skilled traders, general maintenance employees or outside contractors who construct, maintain, and repair utilities systems, buildings, and equipment.
• Sets priorities and performs forecasting and allocates the resources needed to complete all preventive and corrective maintenance tasks.
• May be responsible for building, maintenance, and repair budget for some or all of the facility, depending on scope and span of control.
• May be responsible for maintenance of high voltage systems, utility infrastructures, steam generators, and piping systems.
• Provides support to production services by ensuring that maintaining equipment, power, and light services for all facilities.
• Submits and maintains the annual FME Budget (for Facilities).
• Develops a 10 year ‘Look Ahead’ Budget for Facility Improvements and submits to the VCMP Director.
• Responsible for managing the Preventive Maintenance and Work Order Program.
• Manages the Maintenance Service Agreement (MSA) program. Write scopes of work and justifications to set up and maintain MSA’s.
• Manages unplanned repairs through the Request for Vendor Service (RVS) Program. (For 7116/7114/VPPL).
• Is the Point of Contact on IDIQ contracts for Facilities (writes project scopes, does cost estimate and develops annual budgets for Facility Improvement Projects.
• Manages Snow Removal Contractor and in-house response to storms.
• Uses Regulatory Asset Manager (RAM) for maintenance management.
• Schedules preventive maintenance tasks with in-house and contracted resources.
• Is Property Officer for over 3000 pieces of Government owned equipment.
• Writes SOP’s and Working Practices for Facility Operations.
• Performs biennial reviews and updates on all Facility SOP’s.
• Represents facilities for incident reports, Deviations, CAPA’s, change controls and other GMP reporting.
• Manages subcontracts for a variety of building services, including landscaping, snow removal, waste removal, recycling, preventive maintenance, renovations and repairs.
• Manages multiple trade personnel (HVAC, Electrical, Architectural, Stationary Engineer and Instrumentation) in the maintenance team he supervises.
• Performs SOP training for staff members.
• Manages construction renovations and expansion activities.
• Provides support to the client (VPPL Gaithersburg and VRC) for equipment purchasing, equipment repair, service agreement budget and maintenance service agreements.
• Manages Annual and Biannual Pressure Vessel Inspections with the State of Maryland (boilers and all pressure vessels).
• Coordinates waste water treatment program with Frederick County. Interacts with the inspector and manages water sampling and reporting.
• Oversees chemical water treatment program for chillers and boilers.
• Manages Process Gases and Liquid Nitrogen delivery and supply program.
• Manages grounds keeping (contractor does weekly cutting, Spring/Fall landscaping/mulch, replacement of trees, etc.).
• Responsible for maintaining fuel for Emergency Generator.
• Maintains Building Security System.
• Provides 24/7/365 Emergency Response for all Facility-related work.
• Manages Building Automation System (BAS).
• Manages Scientific Alarm System (SAS).
• Manages Pest Control Program. Writes the contract scope. Performs trend reports and scheduled QA assessments.
• Manages Waste Program (recycling, trash and hazardous).
• Perform Annual Sprinkler and Fire Alarm Testing and required reporting.
• Assists with planned VCMP QA audits and client-directed QA/Regulatory audits.
• Manages all building plant and process equipment and operations.
• Maintains construction and project as-built drawings.

BASIC QUALIFICATIONS

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

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of six (6) years experience working in building maintenance or construction management including two years exposure in a cGMP environment.
  • Also including four (4) years as a manager.
• Ability to effectively plan, organize and lead maintenance activities.
• Must possess basic Microsoft Office skills.
• Must possess basic Microsoft Excel skills.
• Ability to translate program requirements into work orders.
• Coordinate renovations.
• Prepare and monitor budgets.
• Provide appropriate response in emergency situations.
• Perform on-site technical inspections of equipment and systems to assure they are being maintained in good operating condition.
• Knowledge of operation of building utilities.
• Technical operations to the extent required to communicate with scientific staff.
• Have a clear understanding of cGMPs related to the maintenance and operation of critical utilities, process and analytical equipment.
• Must demonstrate competence in managing pharmaceutical or biotech facilities, overseeing contractor services in support of facilities, and in supervising technical and support employees.
• Ability to be on-call for facility emergencies.
• Ability to write and present reports on building status to upper management.
• Ability to determine emergency situations and make decisions within scope after obtaining appropriate approvals.
• This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Facility Management Professional Certification through the International Facility Management Association or equivalent.
• Dedicated training in safety and OSHA-compliant maintenance and construction operations.
• Experience with the development and updating of policies and procedures.
• Experience managing multiple building/facility locations.

PHYSICAL REQUIREMENTS

• Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, carry up to 50lb, lift >50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods.
• Ability to obtain confined space certification.
• Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
• Ability to wear Personal Protective Equipment (PPE).
• Ability to Enter a Laboratory or Encounter a Hazardous Area.
• Ability to Kneel.
• Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas.
• Pacemaker prohibited.
• Repeated bending.
• Exposure to temperatures below 32 degrees indoors for small amounts of time.
• Exposure to temperatures above 90 degrees indoors for small amounts of time.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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