Senior Scientist, Reagent Quality Control

Organization
Genomic Health
Job Location
Redwood City, CA 94063
Job Description

As the Senior Scientist, Reagent Quality you will be an integral part of Genomic Health's Operations team, with primary responsibility for the development of Quality Control (QC) test methods and specifications for purchased and in-house manufactured reagents and consumables. In this role you will contribute to the development of new products, new processes, and ensuring the consistent quality of materials used in commercial patient sample testing within our Clinical Laboratory. You will lead and participate in efforts to create and implement quality testing methods, stability data, study protocols and reports, and standard operating procedures to ensure that any quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory. You will partner with Biostatistics, Quality, Supply Chain, Engineering, and Clinical Laboratory personnel in investigation of reagent quality issues, help drive continual improvement in efficiency of QC and manufacturing workflows and the effectiveness of QC methods, and train department staff in new processes. 

The high complexity nature of the work demands in-depth understanding of reagent and consumable QC testing, analytical methods and technology, and regulatory requirements. You should also demonstrate strong verbal and written communication skills, good attention to detail, ability to multi-task, be flexible with tasks and schedules, and have experience working both independently and in a team environment.


  • Lead or participate in cross-functional team efforts to develop, validate, and implement quality control test methods for new reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies.
  • Partner with Genomic Sciences, Biostatistics, and other functions in the development and use of appropriate test methods for characterizing the composition, functional performance, and stability of reagents and consumables required for the development and launch of new products.
  • Draft and implement new procedures, documents, and forms associated with reagent quality testing.
  • Collaborate closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to address and prevent supplier quality issues.
  • Assist in investigation and resolution of reagent / consumable-related issues with our laboratory processes (e.g. investigating special cause variation, changes in failure or repeat rates, other unusual behavior of reagents, consumables, or data), including assessment of impact, root cause identification, and appropriate corrective and preventive action.
  • Ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities.
  • Additional responsibilities as assigned.
Requirements

 

  • Bachelor's degree in a molecular biology, biochemistry, chemistry, or an associated relevant field with 10+ years relevant industrial experience. Advanced degree preferred.
  • Strong background in biochemistry and molecular biology methods with experience in reagent development, manufacturing, and QC for nucleic acid isolation, purification and quantitation, qPCR, and next generation sequencing assays.
  • Experience with transfer and scale up of new products and processes to manufacturing and/or QC.
  • Highly motivated, detail oriented individual with consistent record in solving technical problems effectively and efficiently.
  • Strong communicator with ability to maintain open communication and collaboration with colleagues, management, and suppliers as needed.
  • Ability to prioritize and adapt to changing priorities while maintaining a high standard on quality.
  • Ability to work in a fast paced, multidisciplinary and dynamic environment and capable of handling multiple activities simultaneously.
  • Previous experience in working under ISO13485 quality system and design control practices is highly desirable.





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