QC manager, Supervisor, Microbiology (NCI) (649131)

  • 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.


Reporting to the QC Manager, Microbiology, this position will:

  • Manage the environmental monitoring and utility testing programs
  • Manage and schedule analysts for manufacturing and laboratory support
  • Plan activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
  • Manage environmental monitoring and utility testing data in the MODA database
  • Interpret test results, compare established specifications and control limits, and make recommendations on appropriateness of data for release
  • Perform environmental monitoring and utility testing investigations
  • Assist with the generation of qualification protocols and final reports
  • Manage EM and utility testing qualification protocol execution and data review
  • Participate in internal assessments, audits and resolutions
  • Evaluate procedures to ensure compliance with regulatory standards



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 education requirements, a minimum of four (4) years progressively responsible job related experience in a cGMP environment, including one (1) year of experience in a leadership capacity
  • Must be able to obtain and maintain a security clearance
  • Knowledge of cGMP operations, cleanroom environment and production isolators used for aseptic pharmaceutical filling
  • Strong understanding of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products
  • Strong understanding of cGMPs as they relate to manufacturing operations
  • Ability to write and follow standard operating procedures
  • Possess working knowledge of EM and utility testing databases
  • Ability to lift up to 35 pounds and work in a BL2 environment


Candidates with these desired skills will be given preferential consideration:

  • Demonstration of previous leadership skills
  • Experience with the MODA database specifically the ability to update work items
  • Experience performing EM and utility sampling/testing, including execution of validation protocols

Expected Competencies:

  • Team supervisor of technical and/or non-professional roles, focusing on team completion of assignments and routines
  • Accountable for meeting day-to-day and short-term targets, by setting priorities for the team to ensure task completion impacting the immediate work area
  • Takes action to monitor costs related to team
  • Beginning to have more of contributory impact on team/discipline performance, generally limited to short-term team performance and occasionally on medium-term goals
  • Decisions are guided by policies, procedures and business plan; receive guidance and oversight from manager
  • Knowledge within a single work area and acquires depth of expertise in more than one technical work area and on track to becoming a discipline expert
  • Resolves issues, which are often varied and non-routine, requiring some fact finding, clarification and basic analysis
  • Exchanges standard / basic technical or non-technical information with colleagues and immediate superiors and/or customers
  • Requires objective review of routine work problems, obtaining cooperation or approval

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 www.Leidos.com. 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