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Vaccine Manufacturing Fermentation Lead

Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: October 29, 2019

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. KEY ROLES/RESPONSIBILITIES Support manufacturing laboratory functions Maintain bacterial and mammalian cell cultures Operate/troubleshoot single use and stainless-steel bioreactors, benchtop lab equipment, GMP autoclaves, and other associated equipment Follow standard operating procedures Complete batch production records under current good manufacturing practices Document in detail, through the use of batch production records, the processes and manufacturing steps taken during the procedures Lead production activities in the manufacturing area Train others within the working group and provide feedback to the manager Interface with quality control/quality assurance Write/revise standard operating procedures (SOP) Assist with investigations, write initial deviation responses BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (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 five (5) years of progressively responsible job-related experience with progressively responsible job-related experience in a pharmaceutical cGMP environment Experience with cGMP cell culture manufacturing and production equipment Ability to troubleshoot cell culture process and associated equipment, especially experience with bioreactors Ability to assist in complex investigations including root cause analysis and corrective action determination Working knowledge of cGMP's 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 Good Manufacturing Practices Ability to be gown certified Cleanroom and BL2 experience Ability to lift up to 35 pounds and work in a BL2 environment This position may require working on 2 nd or 3 rd shift and weekends as needed Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Previous lead associate experience a plus Ability to interface with Quality Control, Quality Assurance, Materials Management, Facilities and Validation JOB HAZARDS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Keywords: Frederick National Laboratory for Cancer Research, Frederick , Vaccine Manufacturing Fermentation Lead, Other , Frederick, Maryland

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