• Posted on: Jul 20, 2022
  • Location: Saint Louis, MO
  • Job ID: 78c718df
  • Type: Full Time
  • Category: Executive
  • BLS Category: 17-2199 Engineers, All Other
  • Posted on: Jul 20, 2022
  • Location: Saint Louis, MO
  • Job ID: 78c718df
  • Type: Full Time
  • Category: Executive
  • BLS Category: 17-2199 Engineers, All Other

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We are searching for a Senior Director of Continuous Improvement for a highly regarded pharmaceutical company. The Senior Director will be

lead the design of process, systems and governance for new product development (NPD). He or she will use sustainable processes to develop innovative project management techniques, advanced scheduling methods, simulation, and transactional Lean principles. The Senior Director of Continuous Improvement will manage cross functional teams executing projects primarily focused on new product development and manufacturing.
Requirements for the Senior Director of Continuous Improvement:
  • Bachelor’s degree in engineering or related science degree
  • 10+ years in a dedicated continuous improvement or operational excellence assignment.
  • PMP and MBA preferred
  • Strong background in organic and inorganic chemistry preferred
  • 10+ years of combined engineering and continuous improvement experience in the pharmaceutical industry; aseptic sterile parenteral experience preferred.
  • Extensive knowledge of cGMP, ICH/FDA QBD (Q8/Q9/Q10), NDA/ANDA CMC modules and pharmaceutical process validation principals.
  • Demonstrated application of statistical methods for evaluating drug stability, consistent with ICH/FDA Q1E.
  • Certified Six Sigma Black Belt. Master Black Belt preferred.
  • Experience in designing, implementing and growing continuous improvement deployments at the enterprise level.
  • Demonstrated outcomes of achieving annual EBITDA improvement of at least $1.5 million.
  • A track record of excellence in developing and delivering continuous improvement training programs, development and certification of Six Sigma Black Belt / Green Belt candidates.
  • Subject matter expert in data analysis, empirical model building and statistical hypothesis testing (parametric and non-parametric). Expertise in linear, non-linear, ordinal and binary regression.
  • Demonstrated use of Monte Carlo simulations applied to problem solving, project scheduling, financial analysis and strategic portfolio analysis preferred.
  • Measurable success from the application of statistical design of experiments (DOE) for both new drug development and optimization of commercial pharmaceutical operations. Subject matter expert in factorial DOE, response surface DOE, robust design techniques (Taguchi methods) and constrained mixture design.

Occupational Category: 17-2199 Engineers, All Other

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Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.
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