Manufacturing Fill Finish Lead (NCI)

Leidos FREDERICK, MD Closed
Leidos is looking for Manufacturing Fill Finish Lead (NCI) in FREDERICK, MD. This local job opportunity with ID 11118078 is live since 09/25/2018.
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 into the Fill Operations Manager, the Fill Finish Lead will:

  • 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 schedules and performance requirements
  • Write standard operating procedures
  • Review batch production records
  • Serve as a lead technician within assigned area
  • Train others within the working group and provide feedback to the manager
  • Interface with Quality Control and 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
  • In addition to the education requirements, a minimum of five (5) years progressively responsible related experience; or three (3) years progressively responsible experience in a cGMP environment
  • Experience with cGMP operations, cleanroom environment and production isolators used for aseptic pharmaceutical filing
  • 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
  • May be required to work on 2nd or 3rd shift as needed
  • 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 as a lead technician in a GMP environment

Expected Competencies:

  • Career-level (fully competent) experienced professional able to carry out a full range of professional duties, but working independently and receiving minimal guidance
  • Produces professional know-how to enhance the knowledge and skill base of the organization
  • Accountable for meeting own target which will impact the program
  • Impact is limited to the achievement of short- to medium-term goals
  • Contributes to delivery of department goals through personal effort or through influence over team members
  • In-depth knowledge of principles and practices within a professional discipline
  • Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variants in approach
  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues which may impact the longer term
  • Solves complete problems; takes a new perspective using existing solutions
  • Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences
  • Acts as a resource for colleagues with less experience; may direct the work of other staff members


Employer Overview:
Employer 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, Employer 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 Employer with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Employer.com. The company’s diverse employees support vital missions for government and commercial customers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Employer will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Employer is an equal opportunity employer/disability/vet. read more

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