Senior Specialist, Investigations and Operational Excellence

2 weeks ago

Alameda, California, United States Enigma Search Full time

Enigma Search is looking for a Senior Specialist, Investigations and Operational Excellence to play a pivotal role in a cutting-edge Cell and Gene Therapy organization. In this position, you will spearhead Investigation Management and contribute to the enhancement of Operational Excellence.

Key Responsibilities: Investigation Management

  • Conduct thorough investigations into process deviations and laboratory discrepancies, ensuring preventive measures are in place to support manufacturing and quality control operations.
  • Draft comprehensive investigation reports that provide actionable recommendations for medium to high severity deviations.
  • Analyze data gathered from investigations, synthesizing findings and trends into detailed reports.
  • Present investigation outcomes and recommendations during team meetings.
  • Review completed production records and documentation in accordance with current Good Manufacturing Practices (cGMP) to support investigations.
  • Edit and update controlled documents (such as batch records, logbooks, SOPs, and test records) to maintain compliance with established procedures.
  • Monitor production workflows to gather essential data that supports investigations and assesses the effectiveness of implemented changes.
  • Participate in or lead cross-functional teams to achieve investigative objectives and support the documentation of findings.
  • Collect, analyze, and trend process and analytical data to promote consistency and timely responses.
  • Document training activities and mentor new staff on investigative methodologies and processes.
  • Develop and maintain templates and tools to enhance investigational consistency and excellence.
  • Coordinate and lead meetings across various departments to foster collaboration.

Key Responsibilities: Operational Excellence and Continuous Improvement

  • Lead and facilitate initiatives aimed at process enhancement (including Lean/DMAIC projects, rapid process improvements, and Kaizen events) with minimal supervision throughout all project phases: initiation, planning, execution, monitoring, and closure.
  • Deliver high-quality outputs across multiple projects concurrently by applying effective project management skills, including the creation of clear project charters, timeline management, data collection, analysis, and communication strategies.
  • Gather and analyze data to establish baselines, enabling root cause analysis, opportunity identification, solution development, and implementation.
  • Serve as a subject matter expert, coaching personnel at all levels on Operational Excellence principles, systems, and tools. Educate teams on process improvement methodologies and project management concepts to enhance organizational capabilities.
  • Collaborate with department leaders to identify relevant metrics that align with business goals, providing guidance on data collection, analysis, visualization, and control plans to achieve results and ensure sustainability.
  • Assist leadership in developing, implementing, and refining an efficient Daily Management System that connects management with frontline operations.
  • Champion the vision of Operational Excellence and act as a change agent to foster a culture of continuous improvement throughout the organization.

Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related discipline.
  • Advanced degree (e.g., Master's, Ph.D.) is preferred.
  • A minimum of five years of relevant experience in Operational Excellence or continuous improvement environments, with at least three years in a dedicated role.
  • Experience in manufacturing, particularly within a biopharmaceutical context and/or Cell and Gene Therapy.
  • Certification as a Lean Six Sigma Yellow Belt or higher.
  • Demonstrated ability to facilitate and lead multiple initiatives from current state to desired future state, with involvement in strategy and execution.
  • Proficient knowledge of and experience in implementing process improvement tools.
  • Exceptional communication, interpersonal, influencing, change management, and leadership skills.

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