657671 - Materials Prep Manufacturing Associate (NCI)

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 Materials Prep Manager, the Materials Prep associate will:

* Weigh raw materials

* Operate advanced buffer/media skid

* Perform buffer preparation/formulation

* Assemble tubing sets

* Working with GMP autoclaves, scales, filter integrity testers, pH and conductivity meters

* Working in downflow booth, fume hood, and Biological Safety Cabinet (BSC)

* Perform aseptic gowning

* Follow Standard Operating Procedures (SOPs)

* 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

* Interface with Quality Control and Quality Assurance

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

* No experience required with a Bachelor's degree

* Ability to be gowning certified

* Cleanroom and BL2 experience

* Ability to lift up to 35 pounds

* This position may require working on 2nd or 3rd shifts and weekends, as needed

* Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

* Buffer preparation/formulation

* Weighing raw materials

* cGMP experience

Expected Competencies:

* Entry role, contributing in a support capacity by receiving instruction, guidance and direction from others

* Accountable for meeting own targets which impact the immediate work area

* Impact is limited to short-term team performance

* Responsible for planning own work, assessing own progress, and adjusting efforts to meet goals

* Applied knowledge of standardized rules, procedures, and operations within own area

* Determines a course of action based on guidelines and competence developed by performing structured work assignments

* Uses existing procedures to solve routine or standard problems, and occasionally requires basic problem-solving techniques to define problems

* Generally knowledgeable about the subject matter but may be required to interpret or clarify technical information to aid understanding

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. 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. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.