ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Quality Control Scientist.
The QC Scientist will be responsible for writing validation strategies, protocols and reports. The scientist will participate in the execution of validation protocols, ensuring that all materials and requirements are met. The QC Scientist will trend QC data, perform statistical analysis, and improve and/or troubleshoot assays. In addition, the Scientist will participate in routine QC analytical testing of raw materials, in-process material and finished product.
- Responsible for writing analytical method validation strategies, protocols and reports.
- Responsible for developing, executing, and writing development reports in support of validation
- Performs statistical analysis analytical methods
- Solves analytical problems and troubleshoots assays
- Performs data trend analysis, communicates trending data to team
- Responsible for completing Risk Analysis and pFMEAs.
- Writes and updates standard test methods and standard operating procedures
- Responsible for conducting routine and non-routine analysis of raw materials, in-process, and finished product according to standard test methods. Test methods include gel electrophoresis, spectrophotometry, immunophenotyping, bioburden, endotoxin, cytometric bead assays, flow cytometry, and northern blot analysis.
- Perform other duties as required.
- BS degree in scientific discipline with minimum 5 yearsâ€™ experience in biotech/pharmaceutical/medical device industry.
- Experience in method and/or process validation.
- Thorough knowledge of cGMP/ICH/FDA regulations as they relate to biopharmaceuticals. Excellent record keeping abilities.
- Experience in experimental design, data gathering, statistical analysis of data and interpreting and presenting results.
- Must have strong computer skills.
- Good communication and interpersonal skills required.
- Must have initiative, high attention to detail, and the ability to multi-task.
- Ability and willingness to be regularly, predictably and reliably at work.
- Flow cytometry as well as molecular biology experience preferred.
- Certified Six Sigma Green Belt preferred.
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.