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Manufacturing Inoculum Prep Associate
Job ID: req2848
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 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 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.
KEY ROLES/RESPONSIBILITIES
Reporting to the Manager, Manufacturing Inoculum Prep Operations, the Manufacturing Associate will:
  • Complete tasks supporting manufacturing laboratory functions
  • Perform aseptic techniques to maintain bacterial and mammalian cell cultures
  • Utilize controlled and monitored CO2 incubators, automated cell counting analyzer, 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, with minimal troubleshooting required
  • Follow and adhere to Standard Operating Procedures (SOP)
  • Complete batch production records under current Good Manufacturing Practices (cGMP)
  • Document in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Write and revise Standard Operating Procedures (SOP) and batch production records
  • Ability to contribute ideas, perform and execute development related work 
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 Science 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
  • Ability to perform aseptic gowning and to be gown certified
  • Cleanroom and BL2 experience
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Ability to work 2nd or 3rd shift and weekends as needed
  • Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
  • Cell culture
  • Aseptic techniques
  • Media and/or buffer preparation
  • Preservation and cell storage
  • Ability to interface with Quality Control, Quality Assurance, Materials Management
  • Independent Laboratory work
JOB HAZARDS
  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)