Process Development Associate III/IV (req2173)

Posted: 10/5/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2173

PROGRAM DESCRIPTION

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

Both Levels require:

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

In addition level IV requires:

  • 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
  • Proficiency in Fermentation and protein purification
  • Experience in process scale-up and technology transfer

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 Process 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) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • 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.
  • Familiarity with AKTA systems/software
  • Experience/knowledge with Microsoft Office software
  • Excellent written and verbal communication skills
  • Ability to obtain and maintain a clearance
    • 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

In addition level IV requires:

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