Lead Specialist, Operational Excellence and Investigative Analysis

2 weeks ago

Alameda, California, United States Enigma Search Full time

Enigma Search is looking for a Senior Specialist, Investigations and Operational Excellence to join our team in the Cell and Gene Therapy sector. In this pivotal role, you will spearhead Investigation Management initiatives and contribute to the enhancement of Operational Excellence. This position offers a hybrid work model.

Key Responsibilities: Investigation Management

  • Conduct thorough investigations into process deviations and laboratory discrepancies, ensuring preventive measures are established to support manufacturing and quality control operations.
  • Draft comprehensive investigation reports that provide actionable recommendations for medium to high severity deviations.
  • Evaluate and synthesize data gathered during investigations, presenting trends and insights in formal reports.
  • Effectively communicate findings and suggestions during team meetings.
  • Review batch records and logbooks to ensure compliance with current Good Manufacturing Practices (cGMP) standards in support of investigations.
  • Edit and revise controlled documents (including batch records, SOPs, and test records) to maintain adherence to established procedures.
  • Monitor production workflows to gather essential data that supports investigations and assess the effectiveness of implemented changes.
  • Participate in or lead cross-functional teams to drive results and support investigation efforts.
  • Collect, analyze, and trend process and analytical data to promote consistency and timely responses.
  • Document training activities and mentor new team members on investigative methodologies.
  • Develop and maintain templates and tools to ensure consistency and excellence in investigations.
  • Facilitate cross-departmental meetings to enhance collaboration.

Key Responsibilities: Operational Excellence and Continuous Improvement

  • Lead and facilitate initiatives aimed at process enhancement (such as Lean and DMAIC projects) with minimal oversight throughout all project phases.
  • Deliver high-quality outcomes across multiple projects simultaneously, utilizing project management skills to ensure clear objectives, timelines, and communication strategies.
  • Gather and analyze data to establish baselines, conduct root cause analyses, identify opportunities, and implement sustainable solutions.
  • Serve as a subject matter expert, coaching team members at all levels on Operational Excellence principles and methodologies.
  • Collaborate with departmental leaders to identify relevant metrics that align with organizational goals, providing guidance on data analysis and visualization.
  • Assist leadership in developing and maintaining an effective Daily Management System to connect with frontline operations.
  • Champion the vision of Operational Excellence and act as a catalyst for fostering a culture of continuous improvement throughout the organization.

Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related discipline.
  • Advanced degree (Master's or 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 the Biopharmaceutical or Cell and Gene Therapy sectors.
  • Certification in Lean Six Sigma (Yellow Belt or higher) is required.
  • Demonstrated ability to lead multiple initiatives from strategy to execution.
  • Familiarity with process improvement tools and methodologies.
  • Excellent communication, interpersonal, and leadership skills.

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