Biopharmaceutical Development Associate

Biopharmaceutical Development Associate

Job ID: req3098
Employee Type: exempt full-time
Division: Biopharmaceutical Development Program
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

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

Biopharmaceutical Development Associate, LEVEL III:

• Design, optimize, and characterize upstream and downstream processes for the manufacture of biopharmaceuticals (viral vectors, 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
  

Biopharmaceutical Development Associate, LEVEL IV:

In addition to Level III responsibilities:

• 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 Biopharmaceutical Development Associate III or IV commensurate with the selected candidates experience.

• Possession of an (CHEA) bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  
  • LEVEL III - In addition to the education requirement, a minimum of five (5) years' experience
    
  • LEVEL IV - In addition to the education requirement, a minimum of eight (8) years' experience
    
• 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
  
• Ability to obtain and maintain a security clearance

LEVEL IV

In addition to Level III:

• Experience running Bioreactors 5 – 30L scale (Bacterial and cell culture)
  
• Experience with large volume harvesting and homogenization
• Experience with Filtration and TFF
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Master’s degree
• 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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