Lead Manufacturing Fermentation Associate

Lead Manufacturing Fermentation Associate

Job ID: req3761
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

• Implements production and large-scale manufacturing procedures to optimize processes and regulatory requirements.
  
• Responsibilities include operating and troubleshooting for upstream equipment (stainless steel and Single Use Bioreactors) and systems.
  
• May establish operating equipment specifications and improve manufacturing techniques.
  
• May assist with resolving technical issues, as well as maintenance of production equipment.
  
• May review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures.
  
• Maintain bacterial and mammalian cell cultures.
  
• 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.
  
• Interact with customers and/or senior management.
  
• Write/revise SOPs.
  
• Perform investigations and write deviations.
  
• This position may require work on 2nd, 3rd, or weekend shifts as needed.
  

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific related field (Qualifying four (4) years relevant experience in GMP manufacturing may be substituted for the required education).
• Foreign degrees must be evaluated for U.S. equivalency.
  
• In addition to the education requirement, must have a minimum of five (5) years of experience.
  
• Must possess basic Microsoft Office skills.
  
• 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 perform aseptic gowning and to be gown certified.
  
• Cleanroom and BL2 experience.
  
• Ability to lift up to 35 pounds and work in a BL2 environment.
  
• Ability to work 2nd or 3rd shift and weekends as needed.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Previous lead associate experience.
  
• Ability to interface with Quality Control, Quality Assurance, Materials Management, Facilities and Validation.
  

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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