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Director of Clinical Optimization
Aliso Viejo, CA  Posted: 6/12/2019



Our client is looking for a Program Manager/Director of clinical optimization. This position will report to the COO and our consultant will be implementing Lean Six Sigma transformations, as well as continuous improvement across the organization. Our client is growing quickly and is willing to invest in the future. Our client is aiming to grow their lab capacity, and as a result, are looking for a leader with a lean six sigma master black-belt. 
Duties & Responsibilities:
  • Drive improvements in delivery and costs by using lean six sigma operating methodology to ensure consistency of operations.
  • Responsible for independently facilitating complex transformation activities, which includes leading large cross-functional teams, incorporating process improvement methodologies into large scale projects / new products and delivering results in specific time frames.
  • Develop Value Stream Maps to determine takt / queue / process lead / processing / cycle times and use that analysis to determine where to perform a Kaizen event
  • Utilize Theory of Constraints and drum-buffer-rope to optimize throughput and revenue in a 24/7 genetic testing laboratory
  • Coach newly trained Green Belts through a Kaizen Event helping the culture make data driven decisions
  • Collaborate with Software Development, Bioinformatics, R&D and other teams to ensure that all new products and processes are introduced in compliance, on time, on budget to ensure operational success
  • Partner with IT, Operations, Quality, Clinical Lab & Reporting to integrate various systems and establish cost controls, staffing metrics, utilization of services, etc.
  • Establish continuous improvement performance targets, measure actual performance and take appropriate and timely corrective action if negative trends emerge for; product quality, capacity, lead time, labor efficiency, space utilization, yield, and business processes effectiveness
  • Create a culture of transparency and accountability for interdepartmental staff to work together and achieve objectives
Position Requirements:
  • Bachelor’s degree in Engineering, Biology, Biotechnology, Molecular Biology, Industrial Engineering, Logistics, Operations Management, or related field
  • Demonstrated experience in leading and resource planning, process improvement, manufacturing and assembly, and systems integration
  • Demonstrated ability to create and sustain a culture of continuous process improvement and waste elimination that yields improvements to quality, delivery, cost and time-to-market using recognized industry Lean and Six Sigma practices
  • Extensive knowledge and experience with technology and IT solutions
  • Extensive knowledge and experience working with product teams, launching new genetic testing products
  • Lean Six Sigma Black Belt or Master Black Belt Certification
Preferred Skills:
  • Master’s of Science degree in similar field
  • 5 or more years of experience in the biotech/pharmaceutical industry or another regulated industry (e.g. life sciences, energy, aviation, nuclear) with a focus on quality, high-throughput testing, assembly, inventory control, systems administration, and process improvement
  • Thrive in a fast-paced collaborative environment within a rapidly evolving business environment
  • Previous experience with implementation and operation of a Laboratory Information System
  • Experience with assay development using liquid handling automation
  • Knowledge of governmental regulations and compliance requirements including CLIA & HIPPA regulatory requirements, health and safety
  • 5 or more years working in a Lean Six Sigma Black Belt or Master Black Belt role
  • 2 plus years with DMADV / DFSS projects
  • Familiarity with SAP



Bachelors or better in Engineering or related field.
Masters or better in Engineering or related field.

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