Supervisor, Vaccine Manufacturing Filling Operations

Job ID: req3334
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 LeidosBiomedical Research at the Frederick National Lab, supports the NationalInstitute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center(VRC). Its’ mission is to advance preclinical and clinical research, productdevelopment, and manufacture of novel clinical-stage vaccines and biologics toaddress 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 plantfacility and is actively engaged in cGMP manufacture, testing, release, andsupply of Phase I /II clinical products for investigational use in the US andglobally.

KEY ROLES/RESPONSIBILITIES

• Oversees and directs the development, planning, implementation andmaintenance of manufacturing methods, processes, and operations for new orexisting products and technologies.
• Works closelywith quality groups to ensure strict compliance with good manufacturingpractices guidelines at all times.
• Preparesdocumentation, reports and standard operating procedures as required. 
• Ensures theeffective use of materials, equipment, and employees in producing qualityproducts. 
• May monitor andcontrol labor and capital expenditures. 
• Selects,develops, and evaluates personnel to ensure the efficient operation of thefunction.
• Perform andschedule drug product component preparation.
• Perform andschedule aseptic formulation and filling.
• Perform andschedule vial inspection and labeling activities under current GoodManufacturing Practices (cGMPs).
• Interface withQuality Control/Quality Assurance, Facility groups, and outside equipmentvendor groups.
• Draftdeviations and change controls.
• Interact withcustomers and/or senior management.

BASIC QUALIFICATIONS

To beconsidered 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 theCouncil for Higher Education Accreditation (CHEA) in a scientific orengineering discipline (Qualifying experience (4 years) in a scientific orengineering field may be substituted for the required education).
• Foreigndegrees must be evaluated for U.S. equivalency.
• In addition tothe education requirement, a minimum of four (4) years’ experience in amanufacturing environment plus two (2) years’ supervisory experience.
• Knowledge ofcGMP operations, cleanroom environment, and aseptic pharmaceutical filling.
• Knowledge ofthe regulatory issues associated with cGMP manufacturing of biopharmaceuticalproducts.
• Knowledge ofcGMPs as they relate to manufacturing operations.
• Workingknowledge of computer assisted manufacturing/production equipment.
• Ability to liftup to 35 pounds.
• Ability to workin a BL2 environment.
• This positionmay require working on 2nd or 3rd shift and weekends as needed.
• Ability toobtain and maintain a security clearance. 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferentialconsideration:

• Experience in barrier isolator technology.
• Experience inlyophilization.

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

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