jobr.pro
Position Location:
We are considering candidates for either our Austin, TX or San Carlos, CA locations
Position Summary: The
Senior Design Transfer Scientist
will be responsible for facilitating the transition of products from Development to Operations. The Sr. Scientist will plan, execute, implement, and document all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The successful candidate will work within the R&D and collaborate cross-functionally with members of operations, bio-development, bioinformatics, quality, regulatory affairs, and clinical affairs.
The Sr. Scientist is expected to divide time between working in the lab and at the desk and providing training and guidance to junior team members in their creation of design transfer documentation and execution of NGS experiments to support in vitro diagnostic (IVD) design transfer. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. This role will also support regulatory IVD and PMA submissions from a design transfer perspective. 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:
Conduct risk assessments (FMEA) to identify gaps in the process and come up with a strategy to make it compliant with IVD standards
Design and develop manufacturing, QC and commercial operations processes
Plan and execute laboratory research in relation to manufacturing scale up and improving process capability
Assure experimental quality through sound experimental design; utilizes DOE, Cpk analysis, Gage R&R and assists in the design of experiments for others
Plan and conduct stability studies with assistance from junior team members
Lead cross functional efforts in establishing supply chain for raw materials and consumables and propose improvements
Attend core team meetings, serve as a voice of operations and liaison between R&D and Operations
Lead test method developments and characterizations
Conduct studies to generate specifications
Set process and test method specifications based on statistical analysis
Lead test method validations and process validations
Set up product structures (BOMs), write SOPs, manufacturing and QC documents etc
Write various protocols and reports
Significant role in PMA submission, audit prep and qualification of suppliers and manufacturing processes
Present status update, data and proposals in various forums to technical and non-technical audiences
Lead junior members of the team
Qualifications:
Bachelor's degree plus 10 years of relevant experience OR a Master's degree with 7 years of experience OR PhD with 4 years of experience required
Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry
Knowledge, Skills, And Abilities:
Extensive knowledge of design control
Experience working to policies; procedures and international quality standards or in a highly regulated industry
Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) is a must
Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
Experience authoring study plans, protocols and study reports is highly desired.
Adept with Excel and basic statistical analysis
Hands-on experience with statistical tools such as Minitab or JMP
Supervise junior scientists and team members in their experimental execution and technical documentation
Experience with nucleic acid technologies relating to NGS, PCR, qPCR and multiplex PCR
Hands-on experience with NGS and DNA/RNA molecular biology is preferred
IVD product development experience is a plus
Very strong analytical and problem-solving skills
Strong interpersonal and communication skills
Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:
Long-Term Equity Awards
Annual performance incentive bonus
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits
Compensation Range $111,000—$138,800 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:
BBB announcement on job scams
FBI Cyber Crime resource page
#J-18808-Ljbffr
Position Summary: The
Senior Design Transfer Scientist
will be responsible for facilitating the transition of products from Development to Operations. The Sr. Scientist will plan, execute, implement, and document all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The successful candidate will work within the R&D and collaborate cross-functionally with members of operations, bio-development, bioinformatics, quality, regulatory affairs, and clinical affairs.
The Sr. Scientist is expected to divide time between working in the lab and at the desk and providing training and guidance to junior team members in their creation of design transfer documentation and execution of NGS experiments to support in vitro diagnostic (IVD) design transfer. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. This role will also support regulatory IVD and PMA submissions from a design transfer perspective. 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:
Conduct risk assessments (FMEA) to identify gaps in the process and come up with a strategy to make it compliant with IVD standards
Design and develop manufacturing, QC and commercial operations processes
Plan and execute laboratory research in relation to manufacturing scale up and improving process capability
Assure experimental quality through sound experimental design; utilizes DOE, Cpk analysis, Gage R&R and assists in the design of experiments for others
Plan and conduct stability studies with assistance from junior team members
Lead cross functional efforts in establishing supply chain for raw materials and consumables and propose improvements
Attend core team meetings, serve as a voice of operations and liaison between R&D and Operations
Lead test method developments and characterizations
Conduct studies to generate specifications
Set process and test method specifications based on statistical analysis
Lead test method validations and process validations
Set up product structures (BOMs), write SOPs, manufacturing and QC documents etc
Write various protocols and reports
Significant role in PMA submission, audit prep and qualification of suppliers and manufacturing processes
Present status update, data and proposals in various forums to technical and non-technical audiences
Lead junior members of the team
Qualifications:
Bachelor's degree plus 10 years of relevant experience OR a Master's degree with 7 years of experience OR PhD with 4 years of experience required
Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry
Knowledge, Skills, And Abilities:
Extensive knowledge of design control
Experience working to policies; procedures and international quality standards or in a highly regulated industry
Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) is a must
Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
Experience authoring study plans, protocols and study reports is highly desired.
Adept with Excel and basic statistical analysis
Hands-on experience with statistical tools such as Minitab or JMP
Supervise junior scientists and team members in their experimental execution and technical documentation
Experience with nucleic acid technologies relating to NGS, PCR, qPCR and multiplex PCR
Hands-on experience with NGS and DNA/RNA molecular biology is preferred
IVD product development experience is a plus
Very strong analytical and problem-solving skills
Strong interpersonal and communication skills
Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:
Long-Term Equity Awards
Annual performance incentive bonus
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits
Compensation Range $111,000—$138,800 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:
BBB announcement on job scams
FBI Cyber Crime resource page
#J-18808-Ljbffr