Director, Continuous Improvement – Biologics Process Optimization Leader

The Director, Continuous Improvement – Process Optimization is responsible for developing and delivering process optimization across the Biologics network, which includes process simplification, complexity reduction, and introducing CI in development, clinical product, and processes. The role will have no direct reports and will work closely with the Site General Managers and Site CI Directors within the Biologics network.

The focus of this Director, Continuous Improvement – Process Optimization will be identifying top pain points/complexity within processes and implementing network-wide solutions to simplify and standardize processes. This will include processes across the make, test, and ship within Biologics while also developing the playbook, tools & measurement systems for process optimization. This position will be identifying and implementing solutions that improve the ability to plan and execute the production of commercial and late-stage clinical products efficiently, timely, and with high quality. The scope of the role covers the entire product lifecycle including M&A, technology, and NPI assessments, but the primary focus of the role will be CI of commercial or clinical products. This Director will launch the COPQ (Cost of Poor Quality) program across the network while also establishing best practices in product transfers within the Product Development (PD) and Manufacturing Science & Technology (MS&T) functions using DFSS, QBD, APQP principles. The position will be highly collaborative and will require extensive leadership and influencing skills along with extensive change management expertise. As part of CI, the Director will develop, implement, and maintain a playbook with the team on how to simplify/standardize processes.

50% travel to sites within the Biologics network

The Role

• Development, management, and execution of process optimization
• Work with multiple sites and teams to roll out the simplification, and complexity reduction with the network. Implement division-wide process re-engineering projects to achieve process improvements and simplification needed to satisfy evolving customer needs
• Standardize/re-engineer processes that can help build scale at a global level
• Identify and implement manual process improvement opportunities that can be automated to achieve process optimization, simplification, reduction in defects, enhanced employee experience and potential cost savings
• Executing process improvement analysis by conducting deep dives to identify gaps and map processes, conduct root cause analysis, formulate actionable recommendations, design solutions and trainings to quantify operational benefits
• Launch the Lean in NPI & proactive problem-solving process using APQP/QBD concepts and use tools like FMEA, DOE, SPC to help sites optimize products and processes
• Support Quality & Continuous Improvement functional teams in building quality right the first time, waste elimination, and overall value creation
• Lead Site project teams to deliver high-quality transformation projects. Establish and maintain relationships with key stakeholders to ensure implementation of the initiatives and ensure they are delivered on time and within budget
  
  
  

The Candidate

• Minimum 12 years experience in Operations and Continuous Improvement roles in complex manufacturing environments. CDMO or Automotive industry expertise a plus
• Black Belt, Master Black Belt or equivalent experience highly preferred
• 8 years experience in leading a team of cross-functional professionals in a portfolio of projects
• 5 years experience in process simplification and standardization
• Substantial hands-on experience with value stream mapping, QBD, APQP, COPQ reduction, etc.
• Demonstrated mastery of quality improvement methods such as LEAN, Six Sigma, Value stream mapping, etc required
• Preferred experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)
• Extensive influential leadership experience; demonstrated change agent with substantial hands-on experience in technical and process problem-solving
• Strong knowledge of cGMP and QbD regulations/guidance pertaining to the pharmaceutical industry preferred
• Demonstrable leadership experience at the company(including but not limited to participation in the company-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
  
  
  

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