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

Mericalherbs

Base: $126,500.00 - $199,100.00; bonus/equity: ann...
Hybrid
Design of experiments (doe)
Statistical process control (spc)
Ich guidance
Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models)

Job Summary

  • Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models).
  • Analyze stability and shelf-life studies aligned with International Council for Harmonisation (ICH) guidance; perform degradation modeling, trend analysis, and shelf-life estimation using regression, mixed-effects models, and tolerance/prediction intervals.
  • The salary range for this role is $126,500.00 - $199,100.00.

Matching Summary

Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models).

Salary

Base: $126,500.00 - $199,100.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Design of Experiments (DoE)
  • Statistical Process Control (SPC)
  • ICH guidance
  • SAS, R, JMP, Minitab
  • Bayesian statistical framework
  • mammalian cell culture and yeast fermentation
  • live virus potency and recombinant protein analytics

Nice-to-have

  • critical thinking and domain knowledge
  • scientific partnership
  • risk and sensitivity analysis
  • practical recommendations for setpoints
  • respectfully challenge one another’s thinking

Key Requirements

  • 10 years BS or 5 years MS or PhD
  • Industrial statistics coursework/experience
  • Pharmaceutical company experience
  • Supporting CMC activities
  • ICH guidelines alignment

Work Rights

Not specified

Tailored Resume

Cover Letter