Manufacturing Associate IV

Job ID: req2745
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.

Position Overview:

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-human clinical studies.


KEY ROLES/RESPONSIBILITIES

• All phases of production (e.g., fermentation, purification, etc.)of clinical, biological and natural products under cGMP conditions
• Document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
• Exercise judgment and use problem solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
• Train others within the working group
• Set up, maintain and operate equipment used in the manufacture of clinical, biological and natural products, including the manufacture of products and in-process testing
• Interface with Quality Control/Quality Assurance
• Write Standard Operating Procedures and complete batch production records

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
• In addition to the education requirements, a minimum of eight (8) years of experience is required
• Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
• Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
• Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
• Ability to work flexible hours including occasional weekends
• Ability to lift up to 25 pounds and work in a BL2 environment
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with large-scale bacterial fermentation equipment and systems
• Experience in the all aspects of cell cultures productions (mammalian, insect etc.)
• Experience with large scale chromatography equipment and systems
• Experience in virus production/purification
• Experience with technical transfer of GMP production processes
• Ability to perform in-process tests such as gel electrophoresis, HPLC, Elisa, Western blot, SDS-PAGE etc.

EXPECTED COMPETENCIES

• Aseptic technique

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
• This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

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

#readytowork