Home




Manufacturing Supervisor Fill/Finish (NCI)

APPLY NOW    
Job Number:
652676
Job Category:
Scientist / Research & Development
Location:
FREDERICK, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM 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.

KEY ROLES/RESPONSIBILITIES

Reporting to the Manager of Fill/Finish, this position will:

  • Supervise manufacturing associates performing fill/finish activities
  • Train others within the working group and provide feedback to the Manager
  • Perform drug product component preparation
  • Perform aseptic formulation and automated filling
  • Perform inspection and labeling activities under current Good Manufacturing Practices (cGMPs)
  • Be responsible for planning production activities within assigned area
  • Assist in the development of budgets, schedules and performance requirements
  • Write/revise standard operating procedures
  • Write/revise batch production records
  • Review/approve batchrecords and related documents
  • Interface with Quality Control/Quality Assurance
  • Interact with customers and/or senior management


Qualifications:

BASIC QUALIFICATIONS

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.
  • Minimum of four (4) years of progressively responsible job-related experience including one (1) year of experience in a leadership capacity
  • Knowledge of cGMP operations, cleanroom environment and aseptic pharmaceutical automated 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
  • Ability to assist in writing master batch records and complete batch production records under GMPs
  • Working knowledge of computer assisted manufacturing/production equipment
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Must be able to obtain and maintain a security clearance
  • PREFERRED QUALIFICATIONS
  • Candidates with these desired skills will be given preferential consideration:
  • Experience in isolation technology
  • Experience in lyophilization
  • Experience as lead technician in a GMP environment

Expected Competencies:

  • Team supervisor of technical 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 and manage costs related to own work and that of the team
  • Beginning to have more of a 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; receives 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 nontechnical 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.
Other Locations:  
APPLY NOW    
Link for schema