- Supports process validation, technology transfer, qualification activities and routine commercial production by authoring protocols, reports and data analyses as well as providing review and quality checking of these documents and supporting data packages.
- Supports commercial drug product trending program by performing analysis of process data with statistical analysis software and assisting with trend visualizations of continuous processes.
- Generates, reviews and quality checks trending data packages and reports
- Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
- Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Ops, Regulatory, Development, suppliers, etc.) to ensure timely completion of data analysis and reports
- Effective written and verbal communication skills
- Established organizational skills
- Ability to collaborate in a team setting
PREFERRED EDUCATION AND EXPERIENCE:
- Has an understanding of drug product manufacturing
- B.S. (or equivalent degree) in relevant discipline with 1-3 years of experience
- Skilled with MS Word and Excel. Proficiency with statistical analysis software such as Matlab or JMP is a plus.
- Experience with technical writing
- An Understanding of pharmaceutical development and manufacturing processes