The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes
Job Summary
The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes.
The role involves designing experiments, analyzing stability studies, supporting scale-up and technology transfer, and preparing statistical content for regulatory submissions.
The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and bonuses.
Matching Summary
The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes.
Salary
Base: $126,500.00 - $199,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation
Skills & Requirements
Must-have
Design of Experiments (DoE)
Statistical Process Control (SPC)
Bayesian statistical framework
Mixed-effects models
CMC documentation support
Stability and shelf-life analysis
Statistical software proficiency
Nice-to-have
Strong consulting skills
Excellent communication skills
Leadership and problem-solving
Cross-functional collaboration
Creative and original thinking
Scientific partnership
Pharmaceutical domain knowledge
Key Requirements
MS in statistics or related field with 5 years experience
Experience in pharmaceutical vaccine manufacturing
Proficiency in SAS, R, JMP, or Minitab
Experience with ICH guidelines
Experience with Bayesian statistics
Experience in mammalian cell culture and yeast fermentation