Manufacturing Associate I, Filling Operations

Frederick National Laboratory is operated by Leidos Biomedical Research, Inc., addressing urgent biomedical challenges in cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases.

About the role

The Vaccine Clinical Materials Program (VCMP) supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics for global infectious diseases (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP operates a pilot plant facility engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products.

Responsibilities

• Complete assigned tasks supporting manufacturing laboratory functions.
• Perform aseptic techniques to maintain bacterial and mammalian cell cultures.
• Utilize CO₂ incubators and Biosafety Cabinets to maintain, manipulate, and propagate cultures.
• Operate basic laboratory equipment such as analytical balances, portable pipettes, autoclaves, depyrogenation ovens, automated filling equipment, and barrier isolators.
• Follow Standard Operating Procedures (SOP) and complete batch production records under current Good Manufacturing Practices (cGMP).
• Perform aseptic gowning and document processes in Production Batch Records or laboratory notebooks.
• Perform drug product component preparation, aseptic formulation, filtration, filling, and controlled rate freezing.
• Conduct inspection and labeling activities under cGMP.
• Operate and change over filling machines and associated equipment, including setup and operation of inspection/labeling equipment.
• Perform filter integrity testing.
• Draft and revise Standard Operating Procedures, Master Batch Records, and Component Specifications.
• Maintain inventory of supplies and components used in the manufacturing process.

Requirements

• Possession of a Bachelor’s degree from an accredited college or university in a scientific field (or four years’ experience in cGMP aseptic fill/finish manufacturing operations may substitute for education).
• Foreign degrees must be evaluated for U.S. equivalency.
• No experience required with a Bachelor’s degree.
• Basic Microsoft Office skills.
• Ability to be gown certified and work in a BL2 environment.
• Ability to obtain and maintain a security clearance.

Physical Qualifications

• Ability to maintain balance, walk, kneel, hear (corrective appliance allowed), use both hands, arms, and legs, and all fingers.
• Lift/carry up to 50 lbs, reach above shoulders, climb ladders, push/pull, bend repeatedly, and stand for extended periods.
• Ability to respond to verbal instruction and cues in a sterile environment where staff wear face masks.
• Ability to wear Personal Protective Equipment (PPE).
• Visual acuity including depth perception, color distinction, and vision correctable to 20/40.
• Ability to enter a laboratory or hazardous area and operate/service equipment contacting compressed or liquid gas.
• Ability to withstand exposure to temperatures below 32°F indoors for short periods.
• Pacemaker prohibited.

Preferred Qualifications

• Cleanroom and BL2 experience.
• Manual and automated filling experience.
• Aseptic isolator operation and technique in Biological Safety Cabinets (BSC).
• VHP decontamination of isolators.
• Lyophilization/freeze drying.
• Formulation/buffer preparation.
• Filter integrity testing.
• Labeling/packaging.
• Ability to interface with Quality Control, Quality Assurance, and Materials Management.

Job Hazards

This position involves working with or potential exposure to infectious material, requiring medical clearance and immunizations.

Pay

Competitive compensation with a posted pay range of $43,800.00 - $62,702.00 USD. The range is a general guideline and may vary based on job responsibilities, education, experience, knowledge, skills, internal equity, and market alignment.

Benefits

Employment benefits include Health and Wellness programs, Income Protection, Paid Leave, and Retirement. More details are available on the Leidos website.