QC Chemist II/III

  • Location: College Station, TX
  • Type: Direct Hire
  • Job #33099

QC Chemist II – Salary: 60K – 75K (DOE)

Biotechnology Company – College Station, TX

M – F: 8am – 5pm

Summary: The Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

Essential Functions:

  • Perform QC analytical testing for GMP in-process, release and stability testing as needed:
    •  PH Conductivity & qPCR required
    • HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred
    • Residual Analysis and/or Surfactant Analysis
    • Osmolality testing
  • Executes technical transfer, qualification and validation protocols as needed.
  • Technical Writing to include:
    • Write and revise Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
    • Qualification protocols
    • Transfer Protocols
    • Creating manuals for processes/activities
    • Sample plans (support & edit)
    • Assisting and initiating closure of deviations, CAPAs and Change Controls
    • Reviewing Methods for accuracy: HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes)
  • Assist with technical training of less experienced members of the team.
  • Facilitate the maintenance and repair of equipment
  • Develop and support a system for managing test samples, reagents and reference standards.
  • Reviews data obtained for compliance to specifications and reports excursion/out of specifications
  • Provides OOS investigational support as needed.
  • Provides QC support for the sites Environmental Monitoring program and raw material analysis.
  • Perform other duties as assigned.

Required Skills & Abilities:

  • Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end, and explain process.
  • Excellent communication skills.
  • Ability to work independently or in a team.
  • Perform as a SME in the designated methods transferred into FDBT.
  • Previous pipetting experience.
  • Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
  • Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
  • Excellent attention to detail.
  • Computer proficiency required.
  • Excellent written and oral communication skills.
  • Excellent organization and analytical skills.

Minimum Qualifications:

  • Master’s degree in Chemistry, Biochemistry or related degree, with 1 year hands on laboratory experience; OR
  • Bachelor’s degree in Chemistry, Biochemistry or related degree with 2 years hands on laboratory experience; OR
  • Associates degree in Chemistry, Biochemistry or related degree with 4 years of hands on laboratory experience,
  • 2 years’ industry experience in a GMP / GxP or a comparable federally regulated environment.

Preferred Qualifications:

  • Familiarity with monoclonal antibody testing methodology.
  • Experience in assay troubleshooting and problem solving.
  • 3+ years’ industry experience in a GMP / GxP or a comparable federally regulated environment
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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