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.
- 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.
- 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.
- 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