MAP Pharmaceuticals, Inc.

Position/Title: Manufacturing Director/Manager

1. Function
   The Manufacturing Director/Manager is responsible for both strategic definition and tactical execution of all MAP manufacturing activities. In particular, these responsibilities include preparation and planning for MAP's commercial manufacturing capacity and capabilities, whether internally operated or contracted. Furthermore, the Manufacturing Director/Manager is also responsible for meeting pre-commercial manufacturing requirements for R&D and clinical trial supplies on all MAP programs. The Manufacturing Director/Manager has specific responsibility for Manufacturing Engineering and Manufacturing Production. These functions include responsibility for specific vendor contracts and agreements, project timelines, and departmental and project budgets. This individual works in collaboration with external design and manufacturing vendors, as well as the internal MAP engineering team, scientists, QA group, and program/project management functions.
2. Specific Responsibilities and Activities
   • Responsible for transition of commercial product from development to manufacturing for clinical trials and for commercial launch
   • Develops and implements systems for high volume manufacturing scale-up
   • Provides management oversight to contract manufacturing sites
   • Works with contract manufacturing sites on site planning, floor layout, tooling, process development, and production
   • Ensures timelines are efficiently communicated and managed
   • Manages and provides leadership to manufacturing engineering and production teams
   • Manage supply chain from 3rd party vendors to 3rd party manufacturing sites, including material and inventory control, shipping, receiving and quality control
   • Implements and manages systems for warehousing and distribution on site or remotely
   • Works with the MAP technical community, including partners and collaborators, to meet internal and external product demand
   • Participates in Design for Manufacturability evaluations and Failure Modes and Effects Analyses and Hazards Analyses in evolving devices through transfer to manufacturing
   • Performs other activities as defined by management and project team requirements
3. Supervisory Responsibilities
   • Directly supervises employee(s).
4. Requirements
   Education
   • B.S. degree in an engineering (such as Mechanical or Industrial Engineering) or operations discipline required (or an equivalent combination of experience and education); master's degree preferred
   Training and Experience
   • Minimum of 10 years experience in increasingly responsible positions in a high volume manufacturing environment, preferably within the drug product or medical device arenas
   • Proven track record of numerous product launches and volume scale-up
   • Demonstrated ability to successfully operate and direct 3rd party manufacturing vendors
   • Thorough understanding of drug manufacturing and packaging processes and/or plastic injection molding and assembly processes
   • Broad knowledge of QC, Regulatory, and other CMC requirements as applied to product manufacturing environment
   • In depth experience with FDA and industry and international regulatory and safety guidelines (21 CFR part 11, GMP, GLP, ISO, etc.)
   Other
   • Excellent communication, interpersonal, and people management skills through all levels of the organization
   • Demonstrated ability to multitask in high pressure, changing conditions in a global manufacturing environment
   • Willing to travel locally, nationally, and internationally up to 20% of time to vendors and contractors
   • Able to lift up to 50 pounds infrequently
   • Must comply with MAP Pharmaceuticals, Inc. safety and corporate policies

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Career Opportunities
MAP Pharmaceuticals, Inc.
2400 Bayshore Parkway, Suite 200
Mountain View, CA 94043

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