Quality Control/Process Analytics Director

Quality Control/Process Analytics Director

Job ID: req3720
Employee Type: nonexempt 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 National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

 KEY ROLES/RESPONSIBILITIES

The QC Group is involved in GMP testing for release of biological products for human clinical trials.  Products include monoclonal antibodies, recombinant proteins, cell therapy products and viral vectors for CAR-T cell products. The director supervises ~ 14 technical staff of the QC Department.

Reporting to the BDP Program Director, the Quality Control/Process Analytics Director 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
• 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 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; provide status reports
• 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
• 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
• Be responsible for the analysis of assay performance through trend analysis, writing stability reports and investigating analytical problems

BASIC QUALIFICATIONS

• Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying four (4) years’ experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of ten (10) years progressively responsible job-related experience in a pharmaceutical or biotech environment including eight (8) years of 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
• Experience with method investigation, Pharmaceutical methodology, and an understanding of process statistics
• Strong technical writing skills
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Masters or PhD in Chemistry/ biochemistry/ molecular biology or other related scientific discipline
• Strong communication skills

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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