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Quality Control/Process Anayltics Director

Job ID: req1493
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

Reporting to the BDP Program Director, this position will be responsible for:

  • Technical direction of the quality control laboratories supporting production of clinical trials materials
  • Maintain laboratory compliance with 21 CFR describing requirements for testing according to good manufacturing practices
  • Assume a pivotal role in review and approval of test results for raw materials, in-process samples, product release and stability testing programs, 4) Serve as the analytical expert on project teams
  • Collaborate with production, QA and administrative staff to meet emerging testing needs in an expeditious manner and mat act as technical project manager on appropriate subcontracts
  • Direct and supervise the quality control department, managing raw materials, in-process and release testing, microbiology, stability and assay validation consistent with good management and GMP practices, purchase and use of appropriate equipment
  • Produce expedient and reliable test results
  • Evaluate at the expert level the accuracy and reliability of reported analytical results
  • Evaluate scientific merit of testing approaches
  • Prepare required reports to defined standards
  • Assist in defining quality approaches to production of products
  • Provide leadership in assay troubleshooting
  • Evaluate and revise SOPs
  • Collaborate with administration to develop budget and staffing projections
  • Provide status reports
  • Identify and communicate out-of-compliance matters
  • Interact constructively with other technical and operations managers as well as the VRC project officer and colleagues,
  • Interface effectively with laboratory, production, quality and administration personnel
  • Oversee quality control operations including raw material testing, environmental monitoring, release testing and the stability program
  • Analysis of assay performance through trend analysis, writing stability reports and investigating analytical problems

BASIC QUALIFICATIONS

  • BS in analytical chemistry, chemistry, microbiology or other related scientific discipline from an accredited college or university.  Foreign degrees must be evaluated for U.S. equivalency
  • Minimum of 10 years progressively responsible job-related experience in a pharmaceutical or biotech environment including 8 years management/supervisory experience in a GMP environment
  • Knowledge of GMP practices
  • Biological assay experience
  • Experience with Analytical instrumentation
  • Demonstrated expertise with analytical methods application and data analysis
  • Well versed in all aspects of a robust quality control programs
  • Method investigation
  • Pharmaceutical methodology
  • Understanding of process statistics
  • Strong technical writing
  • Strong communication skills
  • Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

  • Master’s degree preferred

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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