Frederick National Laboratory for Cancer Research

QC Chemistry Analyst

Location
Frederick, MD
Posted
Jan 14, 2022
Ref
req2253
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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

The QC Chemistry Analyst:

  • Performs basic lab equipment operation, wet chemistry testing, chromatographic testing, spectroscopic testing
  • Performs routine testing of raw materials, and cleaning samples
  • Performs data analysis, compiles data, and prepares results for review
  • Conducts wet chemistry, chromatographic, and spectroscopic testing
  • Participates in internal assessments and audits
  • Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities; This could include validation and revalidation of lab equipment
  • Interprets test results, compares to established specifications and control limits, and makes recommendations on appropriateness of data for release
  • Participates in assay qualifications as part of technology transfer
  • Aids in OOS Investigations and non-conformances

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 Chemistry, Biochemistry, or related scientific 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 2 years of job-related experience
  • Experience in pharmaceutical cGMP environment and demonstrated working knowledge of scientific principles
  • Ability to draft, revise and follow cGMP SOPs related to laboratory instruments and simple test methods, assist with investigations, review data of minimal complexity and compile simple data analysis and report results
  • Ability to execute raw material assay methodologies including spectroscopy, wet chemistry, water/steam testing, and chromatography
  • Ability to work 2nd or 3rd shift as needed (not often)
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

Possess one or more skills in the following areas:

  • Analytical equipment qualification
  • Use of LIMS and complete data analysis
  • Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management
  • Experience with running cleaning samples and assisting in the execution of cleaning validation protocols
  • Experience in a commercial pharmaceutical facility with raw material testing
  • Knowledge of the USP and FDA regulatory guidelines related to raw material testing, product components, and container closure integrity testing

JOB HAZARDS

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