About the position
BioSkryb is seeking a Development Scientist to help manufacture novel genome amplification applications. The individual will help transition developing products through the new product introduction process, coordinating with research scientists on emerging technologies, refinement and testing of products, and development of production procedures and SOPs. The successful candidate will work independently to support the transition of new products from research into production. The minimum qualifications for this role include a PhD in life sciences, 3-5 years of relevant assay development experience, and experience in analytical method development, qualification/validation.
Responsibilities
- Transitioning new products from R&D to Production
- Coordinate with research scientists to commercialize feasible scientific ideas
- Conceptualize and communicate embodiments of product ideas
- Prepare sequencing libraries using existing products and custom solutions
- Interface with external vendors for the qualification of suppliers
- Identify and quantify key metrics that enable assessment of product quality
- Develop procedures and SOPs for assay performance optimization
- Implement methods to inspect, test and evaluate products
- Assist in the development on production KPI’s
- Analyze and present experimental data
Requirements
- Transitioning new products from R&D to Production
- Coordinate with research scientists to commercialize feasible scientific ideas
- Conceptualize and communicate embodiments of product ideas
- Prepare sequencing libraries using existing products and custom solutions
- Interface with external vendors for the qualification of suppliers
- Identify and quantify key metrics that enable assessment of product quality
- Develop procedures and SOPs for assay performance optimization
- Implement methods to inspect, test and evaluate products
- Assist in the development on production KPI’s
- Analyze and present experimental data
- PhD in life sciences
- 3-5 years of relevant assay development experience
- Experience in analytical method development, qualification/validation
- Experience writing and developing SOP’s and documentation procedures
- Excellent oral and written communication skills
- Detail orientated and motivated to move the team forward
- Experience with manufacturing systems preferably MasterControl (preferred)
- Experience designing and executing verification and validation studies in a regulated environment, including stability studies, critical parameter testing, and DoE-driven analyses (preferred)
- Hands-on experience in conducting nucleic acid quantification assays (fluorescence and electrophoretic assays) (preferred)
- Experience in operating Next generation sequencing systems (preferred)