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Associate Director, Manufacturing
Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions. Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations.
We have an exciting opportunity for an Associate Director, Manufacturing. This person will work closely with our Manufacturing staff to transform our organization to commercial readiness.
· Develop staffing plan for the ramp-up of production to a multiple shift operation to support production launch requirements
· Lead the implementation of a Lean Program in the Manufacturing Dept. Focus on
debottlenecking the operation
· Improve training system and drive implementation
· Author and maintain Production related documentation
· Develop and implement short and intermediate term plans to address capacity
· Production interface with Materials Management, PR &D, Quality Assurance, and Quality Control to develop operating systems and assure adherence to schedule
· Lead production related investigations and CAPA actions
· Represent Production on Materials Review Board
· Manage to expense budget and unit-cost targets
· Ensure the development and maintenance of manufacturing support systems needed to maintain production operations; production planning, maintenance/calibration, spare part inventory, etc.
· Foster a culture of compliance and continuous improvement within the Manufacturing Team
· Ensure compliance to all relevant regulatory regulations including cGMP's, DEA and OHSA standards
· Lead the development and implementation of production metrics
· Hands-on leadership for multiple shift manufacturing operation in a regulated environment.
· Ability to work cross functionally, coordinating activities related to product development, project management, facilities, manufacturing and materials management.
· Hands-on knowledge of pharmaceutical cGMP’s and medical device Quality Systems requirements.
· Knowledge of six sigma and lean manufacturing concepts.
· Hands-on knowledge of equipment qualification and validation practices
· Demonstrated team building capability.
Education and Experience:
· 7+ years of proven success in the pharmaceutical, diagnostic and medical device industry with at least 2 years of commercial manufacturing experience
· BA/BS degree required; Degree in engineering or scientific discipline preferred
· Prior experience with manufacturing product for initial commercial launch or significant ramp-up is q requirement; Device/drug combination product experience is desirable
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