BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Product Transfer Scientist to work for a leading San Diego biotechnology company.
Product Transfer Scientist
Actively participate in the development of new products and product improvements as a technical liaison between R&D, Engineering, and Manufacturing organizations. Partner with these organizations to ensure efficient, thorough, and accurate transfer of new product designs to routine production.
As appropriate, provide technical input to other departments with regard to production and development activities such as:
Product risk analysis
Lead, coordinate, or participate in activities required for the transfer of new products to routine production such as:
Raw material sourcing
Scale-up of manufacturing processes
Process development / optimization / transfer
Process / Equipment / Test Method Validation
Develop and maintain documentation related to product design, design change and transfer such as:
Product change orders
Manufacturing procedures / SOPâ€™s
Production flow charts
Proactively identifies both technical and non-technical problems. Leads and / or participates in problem solving efforts.
Minimum of 5 years of development, manufacturing, and / or other relevant experience in the in-vitro diagnostics, medical device, and / or related industries.
Demonstrated knowledge of design controls or other product development / commercialization processes for in-vitro diagnostics or medical device products.
Ability to work effectively with cross-functional core teams as well as external corporate partners. Experience working with external contract manufacturing organizations preferred.
Detail-oriented. Ability to multi-task effectively.
Ability to work within a regulated environment. Familiar with US and EU medical device regulations.
Ph.D. in chemical sciences, life sciences, engineering, or other relevant discipline preferred.