Manufacturing Associate , Inoculum Prep

Job

Employee Type: nonexempt full-time

Division:
Vaccine Clinical Materials Program

Facility:
Frederick: G-WAY

Location:

7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is 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.

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, 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 to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis).

The VCMP is responsible for the operation of a Frederick MD-based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the US and globally.

• Complete assigned tasks supporting manufacturing laboratory functions.
• Perform aseptic techniques to maintain bacterial and mammalian cell cultures.
• Utilize CO₂ incubators and a Biosafety Cabinet to maintain, manipulate and propagate cultures.
• Operate basic laboratory equipment such as centrifuges, analytical balance, portable pipettes, spectrophotometer and automated cell counter.
• Follow Standard Operating Procedures (SOP).
• Complete batch production records under current Good Manufacturing Practices (cGMP).
• Perform aseptic gowning.
• Document, in detail, using Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures.
• Ability to contribute ideas, perform and execute development related work.

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor’s degree in Science from an accredited college/university or four (4) years relevant experience with upstream (cell culture/fermentation/bioreactor) or downstream (column chromatography, buffer/media skid, sterile filtration) biologic production processes under cGMP compliance in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• No work experience required with a Bachelor’s degree.
• Must possess basic Microsoft Office skills.
• Ability to be gown certified.
• Cleanroom and BL2 experience.
• Ability to lift up to 35 pounds and work in a BL2 environment.
• This position may require working on 2nd or 3rd shifts and weekends as needed.
• Ability to obtain and maintain a security clearance.

• Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, use of all fingers, lift/carry up to 50lb, 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 are wearing face masks.
• Ability to wear Personal Protective Equipment (PPE).
• Ability to enter a laboratory or encounter a hazardous area.
• Ability to operate and/or service equipment that contacts or transports compressed or liquid gas.
• Ability to withstand exposure to temperatures below 32°F indoors for small amounts of time.
• Visual acuity to include depth perception and vision correctable to 20/40.
• Pacemaker prohibited.

• Cell culture.
• Aseptic techniques.
• Media and/or buffer preparation.
• Preservation and cell storage.
• Ability to interface with Quality Control, Quality Assurance, Materials Management.

• This position is subject to working with or have potential for exposure to infectious material, requiring…