Manufacturing Associate II - Purification (req2153)

Posted: 9/27/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2153

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 other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

The Manufacturing Associate will:

  • Operate advanced buffer/media skid, chromatographic skid equipment, cGMP autoclaves, and basic lab equipment
  • Perform aseptic formulation and filling, controlled rate freezing
  • Perform in-process sampling, formulation of raw materials
  • Perform column packing/unpacking and qualification of columns from 10 cm to 63 cm ID
  • Operate Tangential Flow Filtration (TFF) filters, holders, and systems
  • Perform filter integrity testing
  • Follow Standard Operating Procedures
  • Complete Batch Production Records under cGMP
  • Document in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures

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 life sciences or a related field or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of related experience
  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Clean room and BL2 experience
  • Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
  • Ability to be gown certified
  • Ability to lift up to 35 pounds
  • This position may require working on 2ndor 3rdshift and weekends as needed

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

Possession of one or more skills in the following areas:

  • Purification experience in contract manufacturing setting is highly desirable
  • Column packing experience
  • Tangential Flow Filtration (TFF) experience
  • 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
  • This position may require continuous or intermittent exposure to and exertion in environmental conditions such as working outdoors, temperature extremes, humidity extremes. etc. as part of the job