Senior Manager, Development and Design Transfer

The posting, as Natera wrote it

POSITION SUMMARY

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.

PRIMARY RESPONSIBILITIES

Design Transfer Leadership

• 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
• 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
• Lead cross-functional efforts to establish supply chain for raw materials and consumables; propose and implement improvements
• Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production
• Communicates progress directly with colleagues and senior management

Team & People Management

• Manages a team of scientists to coordinate the execution of studies to support development of QC methods, verification studies and validation of assays
• Manage and provide leadership for scientists to ensure group effectiveness and development
• Provide technical mentorship and decision-making support for the team
• Monitor performance, deliver timely feedback, and support career development of direct reports
• Foster a culture of accountability, safety, compliance, and continuous learning
• Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership

Cross-Functional Collaboration

• Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product lau

[…]
s include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com .

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information

• BBB announcement on job scams
• FBI Cyber Crime resource page