Actively participate in the development of new products as a representative of Technical Operations to ensure compatibility with current and future manufacturing processes and capabilities.
Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products. Conduct design for manufacturability (DFM) review meetings routinely.
As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, reference material, reagent formulation, and product or consumables testing
Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production:
test method validation
SAP extension and costing
Develop and maintain production documentation including procedures, worksheets, and bills of materials.
Use technical knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation.
Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.
Bachelors with 5 years experience or Master's degree in Life Science with 3 years' experience or Doctoral degree in Life Sciences with 0-2 years' experience.
Experience with Real Time PCR or Manufacturing Operations
Detail-oriented and multi-tasking
Ability to work effectively with cross-functional core teams
Experience within operations/manufacturing
Experience with Design for Manufacturing
Experience in molecular diagnostics development.
Experience with Quality System Regulations.
Familiarity with medical device regulations in US and CE markets
Familiarity with infectious disease or cancer biology.