SUMMARY
- Commercializing Product
- Pilot Studies
- Food Safety Diagnostics
- Policy Development
Responsibilities
- Assists company officers in the development and formulation of long and short-range planning, policies, programs and objectives
- Create project timeline and implementation schedules
- Develop, document and implement quality and manufacturing procedures and polices to satisfy regulatory requirements
- Leads project management of entire life cycle diagnostic product launch for full commercialization for the marketplace
- Leads assessment, contract negotiations and implementation with manufacturing and distribution partners
- Establishes and fully manages contract manufacturing and distribution partners
- Establish and manage procurement and supply chain activities relevant through the project life cycle
- Implement key performance measuring systems to ensure contract manufacturing performance is on point to contract agreements
- Identify, recommend and implement changes to improve productivity and reduce cost and scrap, monitor scrap and rework data relevant to performance in external partners
- Recommends organizational design and resource needs for product launch activities and on-going full launch and operations support
- Perform miscellaneous duties and projects as assigned and required
Qualifications
- Experience managing external manufacturers
- Manufacturing management, preferably in diagnostics industry
- Extensive experience with state and federal laws and regulations applicable to the manufacture of diagnostic products specific to the food safety industry in a GMP environment specific to food safety is preferred
- Preferred experience in all aspects of quality assurance and quality control
- Experience preferred in manufacturing assays for the detection of microbes using conventional microbiology and nucleic acid amplification techniques
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