Responsibilities

• Provide inter-departmental leadership of a group that has the responsibility to establish new process workflows and ensure that these processes are suitable for subsequent automation.
• Provide a clear framework for executing improvements using appropriate tools and a unified approach across the organization.
• Lead the process improvements for pre-established programs to ensure they are operating with Lean principles. This will involve working closely as a team with the manufacturing, supply chain, quality groups and all other pertinent groups to redesign programs for commercial launch readiness.
• Using principles of concurrent engineering, lead teams to ensure manufacturability of design using six sigma approaches.
• Conduct detailed analysis of each unit operation of the process and make recommendations regarding improvements and drive these decisions through the inter-departmental work teams.
• Support specifications in conjunction with the pertinent interdepartmental team and ensure that these specifications meet Alexza’s total requirements.
• Plan and oversee the Agile projects to ensure that the projects from this initiative are completed and meet manufacturing’s needs.
• Continue to establish a formal documented Technology Transfer process ensuring that the participants understand and comply with the process

Skills required

• Good understanding of design control, FMEA and risk assessment
• Demonstrated ability to comply with cGMPs in a viable way as they apply to drug and device development
• Good understanding of Quality System Regulations (QSR)
• Experience with manufacturing of medical products in a cGMP and/or QSR environment
• Strong knowledge and demonstrated use of statistics; strong analytical skills and the ability to rapidly analyze information
• Possess critical thinking skills with the ability to make solid decisions in the face of limited information
• Excellent interpersonal skills to allow effective participation in project teams and the ability to work collaboratively across a number of disciplines and functional groups
• Excellent oral and written communication skills
• Driven and self-motivated
• Detail oriented with the flexibility to evaluate the need for detail against the overall project needs
• Prior experience with regulatory issues related to DEA and the ability to apply these regulations to Alexza’s business needs
• Six Sigma Black Belt, experience with design for manufacturability and Lean principles.

Education and experience

• B.S. or M.S. in Mechanical, Chemical or Materials Engineering or equivalent
• 10 years of process development experience, or Ph.D. in Mechanical, Chemical or Materials Engineering with at least 8 years of process development experience
• Prior experience in the use of six-sigma and process excellence tools
• Experience in the drug development process

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation:

• Starts at $193,100 and is commensurate with experience