We are seeking an Investigations and Operational Excellence SME to join a Cell and Gene Therapy company where you will be leading Investigation Management and help drive Operational Excellence. This is a full-time, hybrid role based in Alameda, CA and will report to the Associate Director, Manufacturing/MSAT.
Key Responsibilities: Investigation Management
- Independently investigate process non-conformances and laboratory investigations and prevent recurrences in support of manufacturing and QC operations.
- Prepare investigation reports that include recommendations on findings for medium/high severity non-conformances.
- Analyze and evaluate information captured through investigations, summarizing information and trends in investigation reports.
- Communicate findings and recommendations at group meetings.
- Review completed batch records and logbooks in line with cGMP standards to support investigations.
- Review, edit, and revise controlled documents (batch records, logbooks, SOPs, test records, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
- Monitor production processes to acquire vital data in support of investigations and track the efficiency of changes.
- Participate in and/or lead cross-functional study teams to achieve results, support, and/or author investigations.
- Gather, trend, and analyzeprocess- and analytical-related data to drive consistency and timeliness.
- Document all training and train new employees on investigative processes and techniques.
- Develop and sustain investigational templates and tools to drive consistency and investigational excellence
- Coordinate and/or lead cross-functional meetings with multiple departments.
Key Responsibilities: Operational Excellence and Continuous Improvement
- Lead and facilitate process improvement initiatives (e.g., Lean/DMAIC projects, workouts/rapid process improvements, and Kaizen events) with minimal oversight through all lifecycle phases: initiation, planning, execution, monitoring and controlling, and closing.
- Deliver timely, high-quality output on multiple projects simultaneously by utilizing project management skills including clear project charters, timeline management, data collection and analysis, and communication plans. Utilize escalation plans and countermeasures when outcomes or timelines are at risk.
- Collect and analyze data to develop a baseline and enable root cause analysis, opportunity identification, solution development and implementation, and sustainment.
- Act as a subject matter expert coaching all levels of the organization in Operational Excellence principles, systems, and tools. Teach process improvement methodologies, project management concepts, and tool application to increase the capability of the business to respond to problems.
- Work with department leaders to identify appropriate metrics at various employee levels that align with business objectives. Provide coaching on data collection, analysis, visualizations, and control plans to deliver results and drive sustainability.
- Provide support to leadership in developing, implementing, maintaining, and improving an efficient and effective Daily Management System to connect them to the frontline.
- Support the vision of Operational Excellence and act as a change agent to instill a continuous improvement culture throughout the organization.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Advanced degree (e.g., Master’s, Ph.D.) preferred.
- Five years of related work experience in Operational Excellence / continuous improvement cultures. Three of these years should be in a dedicated role.
- Manufacturing experience, ideally in a Biopharmaceutical environment and/or Cell and Gene Therapy.
- Certified Lean Six Sigma Yellow Belt or higher
- Proven experience in facilitating and leading simultaneous initiatives to progress from a current state to a desired future state with strategy to execution involvement.
- Knowledge of and experience successfully implementing process improvement tools.
- Strong communication, interpersonal, influencing, change management, and people leadership skills.
