Sr. Statistician – Chemistry, Manufacturing, And Controls (cmc)

Mdcrecruiting

Base: $126,500.00 - $199,100.00; bonus/equity: eli...
Hybrid
Design of experiments (doe)
Statistical process control (spc)
Bayesian statistical framework
The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division, supporting vaccine manufacturing processes and analytical methods

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 and analytical methods.
  • The role involves designing experiments, analyzing stability studies, supporting scale-up and technology transfer, and preparing clear statistical content for CMC documentation aligned with regulatory guidelines.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and sick days, along with eligibility for annual bonuses and long-term incentives.

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 and analytical methods.

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, sick days

Skills & Requirements

Must-have

  • Design of Experiments (DoE)
  • Statistical Process Control (SPC)
  • Bayesian statistical framework
  • Mixed-effects models
  • CMC regulatory documentation
  • Stability and shelf-life analysis
  • Statistical software proficiency (SAS, R, JMP, Minitab)

Nice-to-have

  • Strong consulting skills
  • Excellent communication skills
  • Leadership and project management
  • Creative problem-solving
  • Cross-functional collaboration
  • Scientific partnership
  • Risk and sensitivity analysis

Key Requirements

  • MS in statistics or related field with 5 years experience
  • Experience in pharmaceutical vaccine manufacturing
  • Experience supporting CMC activities aligned with ICH guidelines
  • Proficiency in at least two statistical software packages
  • Experience with Bayesian statistics
  • Background in mammalian cell culture and yeast fermentation
  • Ability to work independently and collaboratively

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter