POSITION SUMMARY:
The Design Transfer Scientist will be responsible for supporting the transfer of products from Development to Operations. The Scientist will assist in planning, execution, implementation, and documentation of all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The Scientist is expected to divide time between working in the lab and at the desk. 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:
- Assist in test method development and characterization.
- Participate in specification generation.
- Plan and execute stability studies.
- Assist in test method validations and process validations.
- Collaborate cross functionally to establish supply chain for raw materials and consumables and propose improvements.
- Participate in collaborative efforts with R&D and subject matter experts for successful transfer of new product designs, including product requirements and material specification development
- Serve as lead on automation projects from a design transfer perspective.
- Perform and document change control activities.
- Write standard operating procedures (SOPs), study protocols, reports and other documentation
- Day-to-day hands on work in the laboratory including generating, recording, and analyzing experimental data
- Present status update, data and proposals in various forums to technical and non-technical audiences.
- Other duties as assigned
QUALIFICATIONS:
- Bachelor's degree with atleast 8 years of experience OR Master's degree with 6 years of experience OR PhD with 3 years of experience.
- Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry.
KNOWLEDGE, SKILLS, AND ABILITIES:
- 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).
- 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.
- Knowledge of design control.
- Adept with Excel and basic statistical analysis.
- Hands-on experience with statistical tools such as Minitab or JMP.
- Experience with scale up and automation projects is a plus.
- Experience with molecular biology techniques such as PCR, qPCR and multiplex PCR is a must.
- Hands-on experience with NGS and DNA/RNA molecular biology is highly preferred.
- Prior Manufacturing and QC experience is a plus
- IVD product development experience is a plus.
- Very strong analytical and problem-solving skills.
- Strong interpersonal and communication skills.
- Effective time management and organizational skills; able to balance multiple priorities
- Excellent communication and analytical skills
- Proven ability to execute and deliver on commitments
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 $108,000—$135,000 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:- BBB announcement on job scams- FBI Cyber Crime resource page
