Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care. Backed by Lightspeed and Sequoia.
About the role
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 Quality Systems Regulations and Design Control. The role will be managing a multidisciplinary group of scientists, providing technical mentorship, and ensuring timely delivery of project milestones. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Advanced degree in molecular biology or related discipline. PhD is preferred, Master’s or Bachelors with equivalent industry experience considered
- 6-8 years of post PhD biotech industry experience or >10 years of post BS/MS biotech experience
- At least 4 years managing a team of scientists and research associates
- Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology
- Proven track record of successful design transfer for assays and medical devices
- Strong understanding of assay development, design control, analytical validation, and manufacturing workflows
More about this role
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 Quality Systems Regulations and Design Control. The role will be managing a multidisciplinary group of scientists, providing technical mentorship, and ensuring timely delivery of project milestones. The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.
- 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...
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