Senior Research Associate, Design Transfer

POSITION LOCATION:

We are considering candidates for either our Austin, TX or San Carlos, CA locations. 

POSITION SUMMARY: 

The Sr. Research Associate, Design Transfer will participate in transfer of new product designs to manufacturing, beginning in the early stage of new product development through implementation. This role's primary responsibilities will include assisting senior scientists in the transfer of new product designs from R&D to reagent and lab operations. Duties will involve creation of Bill of Materials (BOM), QC documentations, running stability studies and other lab experiments etc. The ideal candidate will also be required to spend part of their time formulating and QCing reagents needed for various development and verification studies. This role will focus on carrying out the day-to-day work in the department following directions, practices, and procedures of the group. for next generation sequencing (NGS) assays. 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: 

• Collaborate with R&D scientist in the early stages of the project to build prototypes and become familiar with the assay design.
• Under the supervision of Sr. Scientist, conduct studies to ensure the appropriate product specifications are implemented.
• Create Bill of Materials (BOM).
• Perform engineering change control and document change control activities.
• Write standard operating procedures (SOPs), study protocols, reports and other documentation with guidance from senior members of the team.
• Author manufacturing and QC documentations under the supervision of Sr. scientists.
• Day-to-day “hands on” work in the laboratory including generating, recording, and analyzing experimental data and maintaining laboratory notebooks
• Collaborate with R&D to Build and Test Verification & Validation units.
• Formulate and QC reagents following cGMP practices 
• Work with R&D, Manufacturing, and Quality Assurance to establish the appropriate incoming inspection of parts and outgoing product final test and inspection.
• Participate in the development and validation of QC test methods and release specifications
• Assemble and present data (with guidance) on a regular basis, both individually to supervisors and in departmental meetings
• Other duties as assigned

QUALIFICATIONS: 

• Bachelor's or Master's Degree in biological/chemical or related scientific disciplines
• Bachelor's degree plus 3+ years of relevant experience
• Medical Device and or reagent manufacturing experience is preferred
• 1+ Year Knowledge of routine laboratory methods such as PCR, NGS is highly desirable
• 1+ Year Previous work experience in GLP/GMP laboratory with an understanding of documentation requirements preferred

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Ability to follow established SOPs and in-depth knowledge of GLP/GMP guidelines.
• Experience working to policies; procedures and international quality standards in a regulated industry.
• Experience using an eDMS such as Agile, Arena, Oracle cloud PLM etc.
• Adept with Excel and basic statistical analysis.
• 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.
• Excellent collaboration skills with the ability to work cross-functionally.
• Experience authoring study plans, protocols and study reports is highly desired.

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.Austin, TX$57,700—$99,200 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.