Job Details

Manufacturing Associate – Fill Finish

Job ID: req1647
Employee Type: nonexempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

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

• Perform drug product component preparation
• Perform aseptic formulation and filling and controlled rate freezing
• Perform inspection and labeling activities under current Good Manufacturing Practices (cGMPs)
• Perform operation and changeover of filling machines and associated equipment
• Set up and operate inspection/labeling equipment
• Perform filter integrity testing
• Operate advanced buffer/media skid, cGMP autoclaves and basic lab equipment
• Weigh raw materials
• Perform buffer preparation/formulation
• Perform aseptic gowning
• Follow standard operating procedures
• Complete Batch Production Records under cGMP
• Document, in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures

BASIC QUALIFICATIONS

• 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.
• No experience is required with a Bachelor’s degree
• Ability to be gown certified
• Ability to lift up to 35 pounds and work in a BL2 environment
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Manual and automated filling
• Aseptic Isolator operation
• VHP decontamination of isolators
• Lyophilization/freeze drying
• Formulation/ buffer preparation
• Filter integrity testing  
• Labeling/packaging
• Ability to interface with Quality Control, Quality Assurance, Materials Management
• Cleanroom and BL2 experience

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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