Frederick National Laboratory Job - 39267797 | CareerArc
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Company: Frederick National Laboratory
Location: Frederick, MD
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Manufacturing Associate I/II

Job ID: req1850
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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 Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

  • All phases of production (e.g., fermentation, purification, etc.)of clinical, biological and natural products under cGMP conditions
  • Documenting in detail, using master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Setting up, maintaining and operating equipment used in the manufacture of clinical, biological and natural products, including the manufacture of products and in-process testing
  • Exercising judgment and using problem solving skills to obtain solutions; working to determine methods and procedures on new assignments
  • Interfacing with Quality Control/Quality Assurance
  • Writing Standard Operating Procedures and complete batch production records

BASIC QUALIFICATIONS

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

This position may be filled with a Manufacturing Associate I/II commensurate with the selected candidates experience

  • 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
  • Aseptic technique
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Ability to obtain and maintain a security clearance
    • Manufacturing Associate I - No experience required with a Bachelor's degree
    • Manufacturing Associate II - In addition to educational requirements, a minimum of two (2) years of job related experience 
    • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
    • Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP

PREFERRED QUALIFICATIONS (both levels)

Candidates with these desired skills will be given preferential consideration:

  • Experience with large-scale cell culture equipment and systems
  • Experience with large scale chromatography equipment and systems
  • Experience writing/reviewing technical documents, SOPs and/or master production records and maintaining accurate documentation of laboratory procedures
  • Experience operating/maintaining computerized and complex production equipment
  • Familiarity with cGMP regulations
  • Ability to perform in-process tests such as gel electrophoresis, HPLC, etc.

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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