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Job Description
Senior QC Scientist role involves identifying unknown materials, developing analytical methodologies, and supervising junior team members in a fast-paced laboratory environment.
This role requires a PhD in Biochemistry, Chemistry, Biology or related field and 2+ years of experience in the pharmaceutical or biotechnology industries, or an MSc with 7+ years of experience in the same fields.
Key responsibilities include:
- Executing investigation testing (FT-IR, SEM, ICP-MS, GC) for the chemical identification of unknown material
- Evaluating and interpreting data, authoring and reviewing technical documents
- Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris
- Participating in routine maintenance and troubleshooting of laboratory instrumentation
- Liaising with contract laboratories as required to support investigational analysis
- Tabulating results and writing summary reports of assay development and validation studies
- Presenting findings at group and interdepartmental meetings
- Producing and maintaining accurate records
- Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications
- Participating in technical troubleshooting and investigation
- Supervising junior level group members and acting as a mentor within the laboratory
- Supporting and participating in regulatory inspections
- Participating in cross-functional improvement initiatives/kaizens
- Participating in developing, maintaining and presenting operational metrics
Requirements include:
- Working knowledge of Microsoft Suite (Word, Excel, PowerPoint, etc.)
- Understanding working with statistical software such as JMP
- Development experience in identification-based analyses (e.g. FT-IR, SEM, ICP-MS, GC) in a GMP environment
- Excellent fine motor skills
As a Senior QC Scientist, you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.