Job description
As a QC Scientist for Biochemistry in the Technical Resources Department, a typical day might include the following:
- Participate in assay validation for QC Biochemistry group
- Participate in technical troubleshooting and investigations
- Review new test procedures and assays
- Evaluate and bring in new methodologies/techniques when needed
- Function as a subject matter expert for analytical assay transfer internally and externally
- Review analytical development reports, assay and process validation reports, and other documents for technical correctness and regulatory compliance
- Assist in writing and reviewing technical sections of regulatory submissions
- Opportunity to supervise direct reports in the future
This job might be for you if:
- You are familiar with current industry guidance for analytical methods
- You are able to clearly communicate, collaborate, and compromise to make data driven decisions that take into account the best interest of the company
- You like dealing with technical issues, troubleshooting, and constant change
- You enjoy working cross-functionally with other teams to accomplish great things and change patient lives
- You thrive in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients
- You handle issues appropriately and with a sense of urgency and quality
You have experience with some of the below analytical techniques:
- iCIEF (imaging capillary isoelectric focusing)
- CE-SDS (capillary electrophoresis sodium dodecyl sulfate)
- SDS-PAGE (sodium dodecyl sulphate–polyacrylamide gel electrophoresis)
- MCE (microchip capillary electrophoresis)
- qPCR (Quantitative polymerase chain reaction)
- ELISA (enzyme linked immunosorbent assay)
To be considered for a QC Scientist in QC Technical Resources role in Biochemistry you must have a PhD in Biochemistry, Chemistry, Biology, or a related field. Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred.
Level will be based on experience and qualifications.
- Scientist level requires a PhD and 0-3 years of relevant experience
- Sr. Scientist level requires a PhD and +3 years of relevant experience
Salary Range (annually)
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