Manufacturing Associate – Fill/Finish (NCI) (649193)

  • 02/19/2018

Job Description



The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


The Manufacturing Associate II will:

  • Perform drug product component preparation
  • Perform aseptic formulation and filling and controlled rate freezing
  • Perform inspection and labeling activities under current Good Manufacturing Practices (cGMPs)
  • Perform operation and changeover of filling machines and associated equipment
  • Set up and operate inspection/labeling equipment
  • Perform filter integrity testing
  • Operate advanced buffer/media skid, cGMP autoclaves and basic lab equipment
  • Weigh raw materials
  • Perform buffer preparation/formulation
  • Perform aseptic gowning
  • Follow standard operating procedures
  • Complete Batch Production Records under cGMP
  • Document, in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures



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

  • Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of two (2) years of progressively responsible job-related experience
  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Clean room and BL2 experience
  • Skills/experience in processes and equipment associated with aseptic formulation/filling machine operation/changeover and operation of packaging/inspection equipment
  • Ability to be gown certified
  • Ability to lift up to 35 pounds
  • This position may require working on 2nd or 3rd shift and weekends as needed
  • Must be able to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:

  • Experience with lyophilization
  • Experience in isolation technology

Expected Competencies:

  • Intermediate professional role, responsible for delivery of professional activities while receiving a moderate level of guidance and direction
  • Focuses on providing standard professional advice and creating initial reports / analyzes for review by experienced team professionals
  • Accountable for meeting own targets which impact the immediate work area
  • Impact is generally limited to short-term team performance, occasionally on medium-term goals
  • Beginning to have more of a contributory impact on team performance
  • Requires knowledge and experience in own discipline and company policies, practices and procedures; still acquiring higher level knowledge and skills
  • Determines a course of action based on guidelines and modifies processes and methods as required
  • Uses previous experience, analysis and investigation, to identify the most appropriate option to solve a range of differing, but straightforward problems
  • Understands and communicates fairly complex information within the specialization or recognized body of formal knowledge
  • In some instances, will need to convey information to audiences not knowledgeable of the subject matter

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems Global Solutions business (IS GS). For more information, visit The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer. JBLeidos ICJBMeta