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Development Associate III/IV

Job ID: req1642
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

Development Associates will have the opportunity to do the following:

  • Design, optimize, and characterize upstream and downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and therapeutic proteins) in early stage clinical development 
  • Interpret analytical and process data and understand process implications 
  • Maintain accurate records of experimental results, review, analysis and interpretations of experimental data
  • Make periodic presentations in group meetings, project team meetings, and in one-on-one situations
  • Prepare technical reports 
  • Support technology transfer to in-house clinical manufacturing group
  • Evaluate new technologies to facilitate process development.

 BASIC QUALIFICATIONS

This position may be filled with a Development Associate III/IV 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) in Biochemistry, Biotechnology or related field or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency. 
    • Level III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
    • Level IV - In addition to the education requirement, a minimum of eight (8) years of progressively responsible experience
  • Proficiency in Fermentation and protein purification 
  • Basic knowledge of various aseptic techniques and working in a Biosafety Cabinet
  • Basic analytical techniques for protein products (HPLC analysis, protein quantification methods like gel electrophoresis; ELISA etc. 
  • Experience in process scale-up and technology transfer
  • Familiarity with AKTA systems/software
  • Experience/knowledge with Microsoft Office software
  • Ability to obtain and maintain a clearance

PREFERRED QUALIFICATION

Candidates with these desired skills will be given preferential consideration:

  • Experience running Bioreactors 5 – 30L scale (Bacterial and cell culture)
  • Experience with large volume harvesting and homogenization
  • Experience with Filtration and TFF
  • Excellent written and verbal communication skills

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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