Manufacturing Filling Operations Lead

Job ID: req3474
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 scale-up and 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
  
• Perform drug product component preparation
  
• Perform aseptic formulation and filling
  
• Perform inspection and labeling activities under current Good Manufacturing Practices (cGMPs)
  
• Be responsible for planning production activities within assigned area
  
• 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 Supervisor/Manager
  
• Interface with Quality Control/Quality Assurance
  
• Interact with customers and/or senior management
  

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 (CHEA) in a scientific related field (Qualifying four (4) years' experience in cGMP aseptic fill/finish manufacturing operations may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
  
• In addition to the education requirement, must have five (5) years of experience
  
• Must possess basic Microsoft Office skills
  
• Knowledge of cGMP operations, cleanroom environment and production isolators used for aseptic pharmaceutical filling
  
• 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
  
• Possess working knowledge of computer assisted manufacturing/production equipment
  
• Ability to lift up to 35 pounds and work in a BL2 environment
• Ability 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 lead technician in a GMP environment
  
• Experience in lyophilization
• Leadership qualities from previous positions or employment, such as mentoring lower-level staff members, training fellow staff members, and leading by example

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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