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Vaccine Manufacturing Filling Operations Engineer

Job ID: req1864
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

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

Reporting to the Director, Drug Product Manufacturing, the Vaccine Manufacturing Filling Operations Engineer:

  • Assists in formulation scale up, technology transfer and troubleshooting formulation/solution and/or filling process problems, where analysis of situations and of data requires in-depth evaluation of various factors
  • Exercises judgment within broadly defined practices and policies in developing formulation methods for aseptic drug products, techniques, and evaluation criteria for troubleshooting investigations
  • May determine processing methods and procedures on new technology transfer assignments and may provide guidance to other lower level personnel
  • Serves as POC for formulation/fill tech transfer activities, leading technology transfer team meetings and working directly with government process development scientists in the performance of assigned duties
  • Will be responsible for translating acquired information into process specifications and batch production records and ongoing communications with working groups and project teams 

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 relevant field to (Biochemical engineering, etc. or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirement, a minimum of five (5) years of progressively responsible job-related experience
  • Experience with process transfer project management, formulation/filtration technology transfer, or formulation scale-up in a pharmaceutical cGMP manufacturing environment that includes automated filling operations
  • Experience with equipment and instrumentation associated with drug product formulation, sterile filtration, aseptic filling, solution preparation and analysis (i.e. buffer preparation skids, pH/conductivity meters, osmometers, viscometers/viscosity meter)
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience with Adjuvants including formulation, terminal sterilization, and filling
  • Experience with formulation/ filling of different vaccine platforms e.g. synthetic peptide vaccines; nanoparticle vaccines
  • Experience with formulation/ filling of high concentration monoclonal antibodies
  • Experience in project management and team meeting facilitation

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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