Design Transfer Scientist

Natera • Austin, TX

1d

About The Position

The Design Transfer Scientist will be responsible for supporting the transfer of products from Development to Operations for an early cancer detection assay. 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.

Requirements

• Bachelor's degree plus 8 years of relevant experience OR a master's degree with 5 years of experience OR PhD with 2 years of experience required
• Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry.
• 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)
• Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
• Adept with Excel and basic statistical analysis
• Hands-on experience with statistical tools such as Minitab or JMP
• 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 a must
• 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

Nice To Haves

• Experience authoring study plans, protocols and study reports is highly desired
• Experience with scale up and automation projects is a plus
• Prior Manufacturing and QC experience is a plus
• IVD product development experience is a plus

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
• 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

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees