Process Monitoring and Data Analytics

Knowledge and SkillsExperience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire and R. Basic programming in R and Python preferredExcellent technical writing skillWorking knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferredExcellent troubleshooting skills and ability to solve complex technical issues.Understanding of guidelines required by FDA, EMA, and other regulatory bodiesExtensive knowledge of industry practices.Excellent verbal, written, and interpersonal communication skills are required.Ability to effectively manage multiple projects/priorities.Must Have:Strong background in statistics, process monitoring and advanced statistical data analysis.Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.Support batch processing data collection and verification activities.

Created: 2025-01-19