Manufacturing Solutions Prep Associate

Job ID: req2999
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

• Implements production and large-scale manufacturing procedures to optimize processes and regulatory requirements.
• Responsibilities include scale-up and troubleshooting for equipment and systems.
• May establish operating equipment specifications and improve manufacturing techniques.
• May assist with resolving technical issues, as well as maintenance of production equipment.
  
• May review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures.
• Weighing raw materials.
  
• Operating advanced buffer/media skid.
  
• Buffer preparation/formulation.
  
• Assembly of tubing sets and other required materials.
  
• Filter integrity testing.
  
• Operating GMP autoclaves and basic lab equipment.
  
• Aseptic gowning.
  
• Following standard operating procedures and completing batch production records under current good manufacturing practices.
  
• Documenting in detail, through the use of batch production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures.
  

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 discipline (Qualifying four (4) years' experience in cGMP manufacturing operations may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, two (2) years of related experience.
• Must possess basic Microsoft Office skills.
• Media and Buffer preparation/formulation/filtration/filling experience.
• Strong knowledge of general laboratory equipment (e.g., balances, pH meters, pipettes, etc.)
• Ability to be gown certified.
• Cleanroom and BL2 experience.
• Ability to lift up to 35 pounds.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Weighing raw materials.
• Filter integrity testing.
• Ability to interface with Quality Control, Quality Assurance, Materials Management.
• Writing and revising documentation.
• Good organizational and time management skills.
• Operating advanced buffer/media skid.
• Ability to work within a team setting.

JOB HAZARDS

• This position is subject to atmospheric conditions that would require the usage of a
  respirator, requiring a medical clearance.

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

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