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

leHACK

$126,500.00 - $199,100.00; bonus/equity: eligible ...
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Design of experiments (doe)
Statistical process control (spc)
Ich guidance
** leHACK is seeking a Sr. Statistician specializing in Chemistry, Manufacturing, and Controls (CMC) to provide statistical expertise for vaccine manufacturing analysis and process optimization. The ideal candidate will have extensive experience in statistical methods relevant to pharmaceutical manufacturing and a strong background in experimental design. **

Job Summary

  • Partner with manufacturing teams to define clear objectives, select fit-for-purpose statistical tools, and design/analyze experiments for process optimization and validation.
  • Analyze stability and shelf-life studies, establish ongoing monitoring using SPC/CPV, and troubleshoot OOS/OOT results using advanced statistical methods.
  • Develop reproducible, auditable analyses and prepare clear statistical content for CMC documentation, assisting with regulatory queries.

Matching Summary

Match Score: 75

** leHACK is seeking a Sr. Statistician specializing in Chemistry, Manufacturing, and Controls (CMC) to provide statistical expertise for vaccine manufacturing analysis and process optimization. The ideal candidate will have extensive experience in statistical methods relevant to pharmaceutical manufacturing and a strong background in experimental design. **

Salary

$126,500.00 - $199,100.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision, retirement, paid time off

Skills & Requirements

Must-have

  • Design of Experiments (DoE)
  • Statistical Process Control (SPC)
  • ICH guidance
  • SAS, R, JMP, Minitab
  • Bayesian statistical framework
  • multivariate methods

Nice-to-have

  • critical thinking
  • scientific partnership
  • domain knowledge
  • influencing decision-making
  • original and creative thinking

Key Requirements

  • 10 years BS or 5 years MS or PhD in statistics
  • Industrial statistics coursework/experience
  • Pharmaceutical company experience
  • Experience supporting CMC activities
  • Proficiency in statistical software

Work Rights

Not specified

Tailored Resume

Cover Letter