Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.
POSITION SUMMARY:
The Sr. Manager / Associate Director, R&D Development and Design Transfer (IVD), leads the analytical development and transfer of IVD reagents under Quality System Regulations. Build and manage a team of scientists and research associates to ensure test method and QC development for IVD reagents and successful Design Transfer to Manufacturing and QC teams. Actively collaborates with Natera's technical, regulatory and quality assurance teams and provides technical expertise to ensure compliance to regulatory and quality standards.
PRIMARY RESPONSIBILITIES:
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- Technical lead for method development for quality control for IVD reagents and design transfer under quality system regulation and design control. Responsible for providing technical expertise and leadership in experimental design, experimental execution, data analysis, specification setting and specification validation for test methods.
- Prepare overarching reagent and product stability plans following guidance documents.
- Supervises the activities of direct reports or team members and manages execution of studies to support QC specification setting and validation of those specifications.
- Design stability studies of critical material, intermediates to support the IVD product development and transfer.
- Provide oversight by reviewing and approving analytical method development protocols and reports.
- Development of material specifications for each raw material used in the assay.
- Ensure robust QC specification setting by employing techniques such as DOE, guardbanding, stability and reproducibility testing.
- Act as R&D lead for driving risk management activities related to process/design reagent FMEA.
- Supports process validations as applicable.
- Ensures all studies are conducted under Good Lab Practices and maintains documentation required to meet quality system requirements for Design Control and other international standards (e.g., ISO 13485).
- Interacts with other functional groups, such as, Research, Operations, QA and QC, among others, to find solutions and harmonize on timely deliverables.
- Provides SME support for internal and external audits.
- 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:
- Ph.D. with a minimum of 5-8 years of industry experience. Bachelors/Masters candidates with exceptional track record/experience in R&D Development and Design Transfer can be considered.
- A minimum of 3-5 years of management experience required.
- Prior experience in IVD product development required.
- Prior experience in managing R&D teams
- Experience with Product Development and Design Transfer activities is required.
- Knowledge of quality and regulatory requirements (ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971) is highly desired.
- Hands on experience with Next Generation Sequencing on Illumina platforms is highly desired.
- Mastery of qPCR/multiplex PCR/hybrid capture - primer design, master mix formulation, protocol optimization; fundamental expertise in nucleic acid quantitation and fragment analysis is highly desired.
- Working knowledge of AQL/RQL for setting samples size and acceptance criteria is a plus.
- Knowledge of various approaches for test method validation.
- Very strong analytical and problem-solving skills; organized and efficient
- Proven interpersonal, communication, and presentation skills; excellent time management skills
- Superb attention to detail; produces work of exceptional quality and accuracy
- Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities
- Ability to proactively identify issues and address with solutions-oriented approach
Duties are typically performed in an office setting.
This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
Duties may require working outside normal working hours (evenings and weekends) at times.
Travel required for this position:
No X or Yes _: If yes state anticipated percent for travel:
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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. Generous Employee Referral program. Healthy catered lunches everyday, and premium snacks! Additionally, we offer complimentary premium coffee drinks and teas, and other beverages.
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.