Biopharmaceutical Process Development Associate III/IV

Biopharmaceutical Process Development Associate III/IV

Job ID: req3286
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 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.

KEY ROLES/RESPONSIBILITIES

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 

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:

• 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.
  
  • Assoc III, Process Dev - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
  • Assoc IV, Process Dev- In addition to the education requirement, a minimum of eight (8) years of progressively responsible 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
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Possession of (CHEA) 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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