Method Validation 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 and participate in implementation of improved 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 implementation of a new analytical assay using Real Time PCR platform.
- Perform other duties as required.
- Ph.D degree in Molecular Biology or related discipline with 5 years’ experience or Master Degree with 8 years’ experience in biotech/pharmaceutical/diagnostic industry.
- Expertise in analytical methods utilizing Real Time PCR platform is required.
- 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