Manufacturing Fermentation Associate

Job ID: req3645
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 troubleshooting for equipment 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
  
• Support manufacturing laboratory functions
  
• Maintain bacterial and mammalian cell cultures
  
• Perform microscopic technique/cell counting
  
• Operate single use and fixed stainless-steel bioreactors, GMP autoclaves and associated equipment, basic lab equipment operation
  
• Follow standard operating procedures
  
• Complete Batch Production Records under current Good Manufacturing Practices
  
• Document in detail, through the use of batch production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  
• Initiate deviations when atypical events occur, initiate change controls to improve bioprocessing
  
• Interface with Quality Control/Quality Assurance
  
• Interact with customers and/or Senior Management
  
• 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 science 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 two (2) years of experience in GMP biotech or cell culture/fermentation
  
• Must possess basic Microsoft Office skills
  
• Knowledge of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products
  
• 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
  
• Working knowledge of computer assisted manufacturing/production equipment
  
• Ability to work in a BL2 environment
  
• Ability to lift up to 35 pounds
  
• Ability to be gowning certified
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Cell culture experience
  
• Experience with clarification process centrifugation
  
• Knowledge of various purification technologies of a variety of biomolecules
  
• Ability to interface with Quality Control, Quality Assurance, Materials Management

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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