Design Transfer Scientist

Natera
San Carlos, TX
Category Research
Job Description
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.

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
  • 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
  • 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 a must
  • 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

Benefits

  • Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
  • Free testing for employees and their immediate families
  • Fertility care benefits
  • Pregnancy and baby bonding leave
  • 401k benefits
  • Commuter benefits
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