Manufacturing Associate - Fill/Finish

Manufacturing Associate - Fill/Finish

Job ID: req3030
Employee Type: nonexempt 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

• Operate basic laboratory equipment such as centrifuges, analytical balance, and portable pipettes
• Follow Standard Operating Procedures (SOP)
• Complete batch production records under current Good Manufacturing Practices (cGMP)
• Perform aseptic gowning
• Document, in detail, through the use of Production Batch Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
• Perform drug product component preparation
• Perform aseptic formulation, 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 basic lab equipment, i.e., cGMP autoclaves, high heat ovens, and automated filling equipment  

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) in a scientific related field (Qualifying four (4) years’ experience in cGMP aseptic fill/finish manufacturing operations may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• No experience is required with a Bachelor’s degree
• Must possess basic Microsoft Office skills
• Must be able to obtain and maintain a security clearance
• Ability to be gown certified
• Cleanroom and BL2 experience
• Ability to lift up to 35 pounds and work in a BL2 environment
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATION

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

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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