Manufacturing Manager I

Job ID: req2975
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

• Management of, as well as participation in, fill/finish operations and all ancillary operations, such as buffer and component preparation, environmental monitoring, raw material testing and release, process and equipment validation, etc.
• All of the aforementioned duties and functions are subject to compliance with cGMP regulations
• Recommend, evaluate and/or procure new equipment, as needed
• Prepare and review process documentation
• Supervise 1-2 employees
  
  

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) in computer science, Bioinformatics, Biomedical Science or a related field or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of four (4) years of progressively responsible experience, including two (2) years of experience in a leadership/manager capacity
  
• Thorough knowledge of biopharmaceutical manufacturing operations, particularly with respect to aseptic processing and fill/finish operations
• Complete understanding of cGMP regulations relating to manufacturing operations
• Knowledge of regulatory issues related to products manufactured under cGMPs
• Experience performing analytical testing and working with analytical equipment
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with Flexicon monoblock filling unit
• Supervisory experience
• Experience in other areas of cGMP manufacturing

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious
  material, requiring medical clearance and immunizations
• This position is subject to atmospheric conditions that would require the usage of a
  respirator, requiring a medical clearance

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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