The opportunity
We are seeking an experienced Senior Manager, Design Transfer to lead and coordinate the transfer of products from R&D into Operations. This role will plan, execute, implement, and document all design transfer activities for a next generation sequencing (NGS) IVD/PMA assay under…
What you'll do
Responsible for planning and managing activities and studies from late-stage development to launch
Contribute to design documents, such as reagent stability plans, design: inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partners
Routinely participate in risk management activities (such as hazard analysis,: FMEA) to identify hazards and its causes and propose controls to mitigate risks
Works closely with bioinformatics / statistics groups in aligning with: rationale for study designs and acceptance criteria
Develop and execute detailed design transfer plans
Lead and coordinate design transfer activities from R&D to manufacturing
What they're looking for
- Lead test method development, characterization, and validation
- Conduct studies to generate specifications and set process/test method: specifications based on statistical analysis
- Lead process validations; experience with single-site oncology assay validations is required
- Assure experimental quality through sound experimental design; utilize DOE,: Cpk analysis, and Gage R&R, and mentor others in study design
