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

microsatsystems.biz

Base: $126,500.00 - $199,100.00; bonus/equity: eli...
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Design of experiments (doe)
Statistical process control (spc)
Continued process verification (cpv)
** The Sr. Statistician position at microsatsystems.biz involves statistical analysis and evaluation for the company's Chemistry, Manufacturing, and Controls (CMC) division, particularly in vaccine manufacturing. The ideal candidate should have extensive experience in industrial statistics and be proficient in statistical software, as well as possess strong communication and consulting skills. **

Job Summary

  • Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies, selecting fit-for-purpose statistical tools.
  • Analyze stability and shelf-life studies aligned with International Council for Harmonisation (ICH) guidance, performing degradation modeling and shelf-life estimation.
  • Prepare clear statistical content for Chemistry, Manufacturing, and Controls (CMC) documentation and assist with regulatory queries using sound statistical rationales.

Matching Summary

Match Score: 75

** The Sr. Statistician position at microsatsystems.biz involves statistical analysis and evaluation for the company's Chemistry, Manufacturing, and Controls (CMC) division, particularly in vaccine manufacturing. The ideal candidate should have extensive experience in industrial statistics and be proficient in statistical software, as well as possess strong communication and consulting skills. **

Salary

Base: $126,500.00 - $199,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Design of Experiments (DoE)
  • Statistical Process Control (SPC)
  • Continued Process Verification (CPV)
  • ICH guidance
  • SAS, R, JMP, or Minitab
  • multivariate methods

Nice-to-have

  • critical thinking
  • scientific partnership
  • Bayesian statistical framework
  • mammalian cell culture
  • recombinant protein analytics

Key Requirements

  • 10 years experience with BS
  • 5 years experience with MS
  • PhD with no experience required
  • Industrial statistics coursework/experience
  • Pharmaceutical company experience
  • CMC activities experience

Work Rights

Not specified

Tailored Resume

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