Manager, IVD Product Development

San Carlos, CA

POSITION SUMMARY:
 
The Manager, IVD Product Development manages development of diagnostic assays/processes under Quality System Regulations and Design Control. Focuses on late-stage feasibility and development activities and planning and execution of analytical validation studies to support regulatory submissions. Analyzes data and interprets results.  Maintains broad knowledge of guidance documents and consensus standards used in validating assays for IVD use. Manages junior scientists and research associates/assistants.
 
PRIMARY RESPONSIBILITIES:

  • Responsible for planning and managing activities and studies from late-stage feasibility into development.
  • Responsible for strategizing and execution of innovative solutions for development of assays for regulatory submissions.
  • Lead study design discussions and technical content preparation for pre-submissions to regulatory agencies.
  • Oversees IVD assay development under Natera’s quality system and under design control.
  • Manages a small team of junior scientists and coordinates the execution of studies to support development, verification and validation of assays.
  • Contribute to design documents, such as, design verification plans, reagent and product stability plans, design inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partners.
  • Ensures all verification and validation studies are conducted under Good Lab Practices and maintains documentation required to meet QSR Design Control and other international standards (e.g., ISO 13485, and IVDR requirements). 
  • 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.
  • Interacts with on-site CLIA lab, CDx operations team and other functional groups, such as, Research, Operations, Engineering and Software, among others, to find solutions and harmonize on timely deliverables.
  • Performs basic data analysis (e.g. R, JMP, Excel).
  • Communicates progress directly with colleagues and senior management.
  • The employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
  • Must maintain a current status on Natera training requirements.
  • The employee must pass a post-offer criminal background check.

QUALIFICATIONS:

  • B.S. with a minimum of 8 years of industry experience, OR
  • M.S with a minimum of 5 years of industry experience, OR
  • Ph.D. with a minimum of 3 years of industry experience
  • 2+ years of management/mentoring experience with junior scientists or research associates

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology - experience with Illumina required, other technologies (e.g. PacBio, Oxford Nanopore, Ion Torrent, etc.) a plus.
  • Must have experience with nucleic acid technologies relating to PCR, qPCR, multiplex PCR, digital PCR, NGS, Epigenetic/methylation, target enrichment.
  • IVD product development experience with knowledge of quality and regulatory requirements (ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971) is highly desired.
  • Knowledge of methylation-based technologies and their IVD application is highly desirable.
  • Experience working under Design Control, authoring study plans, protocols and reports is highly desired.
  • Demonstrated experience coordinating interdepartmental efforts, generating research hypotheses, analyzing complex problems and data, and bringing products to market.
  • Strong interpersonal and communication skills.
  • Demonstrated experience in managing and providing leadership/mentorship to research associates and junior scientists.
  • Knowledge of statistical methods and techniques to establish acceptance criteria for analytical studies is desired. 
  • Experience writing study designs, analytical performance summaries for pre-submissions, 510(K) or PMA submission related documentation for molecular diagnostic applications is a plus.
  • Experience with data analysis and interpretation of large data sets, preferably analysis of Next-generation sequencing data using analysis packages such as R, Python, or JMP is a plus.
  • Track record of originating, developing and productizing novel nucleic acid techniques and tests.
  • Strong research skills with a history of innovation.
  • Experience developing tests in oncology, NIPT or liquid biopsy a plus.
  • Proven success in collaborative and individual projects.
  • Demonstrated success in applying independent scientific judgment in experimental design and analysis
  • Very strong analytical and problem-solving skills.
  • Adept with Excel and basic statistical analysis.
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

San Carlos, CA

$136,800 - $171,000 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits 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:
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