ZipRecruiter
Scientist, IVD Product Development
ZipRecruiter, San Carlos, California, United States, 94071
Overview
POSITION SUMMARY: The Scientist/Associate Scientist, IVD Product Development will lead, initiate, execute, analyze, and document product development activities, and verification and validation (V&V) studies, under design control, for next sequencing (NGS) assays. Contributes to technical reports to support regulatory submissions. The successful candidate will work closely within the research and development team as well as collaborate cross-functionally with members of BioDevelopment, scientific operations, bioinformatics, quality, regulatory affairs and clinical affairs. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly, has an interest in our company and our products. Primary responsibilities
Execute development and V&V experiments and analyze data for NGS applications in oncology diagnostics utilizing Natera\'s quality system under design control Plan and execute moderate to high complexity experiments with minimal direction from Manager Coordinate the execution and analysis of studies with biostatistics and bioinformatics teams Contribute to study protocols and technical reports to support FDA submissions Appropriately document experimental procedures and results according to established guidelines (ISO/CLSI, etc.) Ensure that the product meets design requirements, such as design input and output, V&V, etc. Supervise junior scientists and team members in their experimental execution and technical documentation Participate in project planning and updates Assist in executing project plans; participate in defining project goals; develop timelines; and contribute to resource requirements Perform data analysis (e.g. R, JMP, Excel) Support risk management activities (such as hazard analysis, FMEA) Communicate progress directly with colleagues and senior management Qualifications
Associate Scientist:
B.S. with a minimum of 6 years of industry experience, M.S. with a minimum of 2 years of industry experience, or Ph.D. with a minimum of 0-2 years of industry experience Scientist:
B.S with a minimum of 8 years industry experience, M.S with a minimum of 4 years of industry experience, or Ph.D. with a minimum of 2 years of industry experience Knowledge, skills, and abilities
Must have hands-on experience with 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 standards and requirements (ISO, CLSI, FDA) is desired Experience working under design control, authoring study plans, protocols and study reports is highly desired Strong scientific background in molecular and cell biology, experienced in cell-based technologies and bio-analytical assay development Familiarity with methylation-based technologies and their IVD applications is a plus Knowledge of assay development and/or product development in an industry setting is desired Demonstrated experience coordinating interdepartmental efforts, generating research hypotheses, analyzing complex problems and data, and bringing products to market Strong interpersonal and communication skills Skilled at writing clear protocols, reports, and SOPs Track record of contributions towards originating, developing and productizing novel nucleic acid techniques and tests Strong research and product development skills with a history of innovation Experience developing tests in oncology or liquid biopsy is a plus Knowledge of statistical methods and techniques to contribute to analytical studies is desired Ability to follow and establish SOPs and general knowledge of GLP/GMP guidelines Proven success in collaborative and individual projects Ability to work in a fast-paced collaborative team environment 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 Compensation
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 $96,400—$135,950 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. What we offer
Competitive benefits include medical, dental, vision, life and 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 baby bonding leave, 401k benefits, commuter benefits and 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, sex, national origin, age, disability, veteran status, 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-/ 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.
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POSITION SUMMARY: The Scientist/Associate Scientist, IVD Product Development will lead, initiate, execute, analyze, and document product development activities, and verification and validation (V&V) studies, under design control, for next sequencing (NGS) assays. Contributes to technical reports to support regulatory submissions. The successful candidate will work closely within the research and development team as well as collaborate cross-functionally with members of BioDevelopment, scientific operations, bioinformatics, quality, regulatory affairs and clinical affairs. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly, has an interest in our company and our products. Primary responsibilities
Execute development and V&V experiments and analyze data for NGS applications in oncology diagnostics utilizing Natera\'s quality system under design control Plan and execute moderate to high complexity experiments with minimal direction from Manager Coordinate the execution and analysis of studies with biostatistics and bioinformatics teams Contribute to study protocols and technical reports to support FDA submissions Appropriately document experimental procedures and results according to established guidelines (ISO/CLSI, etc.) Ensure that the product meets design requirements, such as design input and output, V&V, etc. Supervise junior scientists and team members in their experimental execution and technical documentation Participate in project planning and updates Assist in executing project plans; participate in defining project goals; develop timelines; and contribute to resource requirements Perform data analysis (e.g. R, JMP, Excel) Support risk management activities (such as hazard analysis, FMEA) Communicate progress directly with colleagues and senior management Qualifications
Associate Scientist:
B.S. with a minimum of 6 years of industry experience, M.S. with a minimum of 2 years of industry experience, or Ph.D. with a minimum of 0-2 years of industry experience Scientist:
B.S with a minimum of 8 years industry experience, M.S with a minimum of 4 years of industry experience, or Ph.D. with a minimum of 2 years of industry experience Knowledge, skills, and abilities
Must have hands-on experience with 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 standards and requirements (ISO, CLSI, FDA) is desired Experience working under design control, authoring study plans, protocols and study reports is highly desired Strong scientific background in molecular and cell biology, experienced in cell-based technologies and bio-analytical assay development Familiarity with methylation-based technologies and their IVD applications is a plus Knowledge of assay development and/or product development in an industry setting is desired Demonstrated experience coordinating interdepartmental efforts, generating research hypotheses, analyzing complex problems and data, and bringing products to market Strong interpersonal and communication skills Skilled at writing clear protocols, reports, and SOPs Track record of contributions towards originating, developing and productizing novel nucleic acid techniques and tests Strong research and product development skills with a history of innovation Experience developing tests in oncology or liquid biopsy is a plus Knowledge of statistical methods and techniques to contribute to analytical studies is desired Ability to follow and establish SOPs and general knowledge of GLP/GMP guidelines Proven success in collaborative and individual projects Ability to work in a fast-paced collaborative team environment 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 Compensation
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 $96,400—$135,950 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. What we offer
Competitive benefits include medical, dental, vision, life and 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 baby bonding leave, 401k benefits, commuter benefits and 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, sex, national origin, age, disability, veteran status, 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-/ 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.
#J-18808-Ljbffr