Scientist II, Development

Organization
Asuragen, Inc.
Job Location
2150 Woodward St.
Suite 100
Austin, TX 78745
Benefits

We invest in your well being: health and dental coverage, stock options for every employee, wellness initiatives, disability coverage, 401(k) plan, professional development and more.

Job Description

 

The Scientist II candidate will be directly responsible for contributing to the development, optimization, and improvement of next generation sequencing (NGS)-based workflows used for the diagnosis of genetic disease and cancer.  The successful candidate will contribute to new and existing products through requirements definition, assay design, optimization, verification, troubleshooting and validation of assays under design control and cGMP.  The focus will be on systems integration and robustness of NGS workflows for oncology.   This role focuses on working collaboratively in cross-functional teams from research, diagnostic development, quality control, software development, bioinformatics, manufacturing operations, and clinical quality.   S/he will be expected to provide input to design, direction, implementation and interpretation of experimental studies.   The Scientist will report directly to a Senior Scientist responsible for process engineering and product transfers.  The successful candidate will apply scientific methods and engineering skills to improve product development and manufacturing processes and be responsible for contributing to protocol generation, report writing and presentation preparation.    The ideal candidate will have prior, demonstrated experience designing, developing, testing, implementing, and supporting PCR- or NGS-based workflows using a requirements-driven approach within the biotech industry or clinical laboratory.

Key Requirements and Duties

  • Contribute as a team member to design and execute experiments in a timely manner with well-organized and documented analysis
  • Author protocols for studies and reports required for process development, improvement, or troubleshooting
  • Obtain data sets that help meet product requirements and drive decision making in project teams
  • Analyze workflows and develop new methods to address identified needs
  • Perform technology and product transfer from research to manufacturing operations
  • Write and review IQ/OQ/PQ documentation, test plans and validation reports
  • Write and review experimental protocols and Standard Operating Procedures, incorporating input from other team members efficiently and effectively
  • Perform laboratory activities including nucleic acid extraction, reverse transcription, quantitative PCR and next generation sequencing utilizing various technologies
  • Participate in interpretation of results and authorship of technical reports
  • Contribute to innovation of current and new assays workflows, technologies and processes
  • Participate in assay finalization and analytical validation of assay methods and processes
  • Support design control in product development including requirements documents, design history files and verification/validation activities
  • Participate in cross-functional process development and improvement teams working to improve efficiency, throughput, cost, and quality
  • Represent process engineering and diagnostic development on cross-functional teams
  • Participate in evaluating commercially available laboratory instrumentation, robotics, and software for integration into existing and new products
  • Other responsibilities as assigned
Requirements

Preferable skills and attributes

  • B.S. / M.S in analytical chemistry,  biochemistry, bioengineering, biomedical engineering, chemical engineering, or a closely-related discipline with a minimum of 2-5 years of relevant experience in a commercial setting is required
  • Experience in streamlining workflows and developing automated laboratory processes and instrumentation systems, including collecting and documenting requirements, developing concepts, design, testing/validation, implementing, and training
  • Demonstrated ability to contribute effectively in cross-functional process development, improvement, and troubleshooting teams
  • Experience with standard molecular biology techniques such as nucleic acid isolation, purification and quantification, capillary electrophoresis, multiplex PCR and next generation sequencing analysis
  • Strong written and oral communication skills with demonstrated track record of successful communication with internal teams, managers and customers
  • A track record of successfully completing complex assignments and meeting goals within aggressive timelines
  • Experience monitoring data quality and troubleshooting technical problems
  • Excellent organizational and planning skills
  • Proficiency in using basic word processing and spreadsheet applications
  • Able to integrate and apply feedback in a professional manner
About Our Organization

Asuragen is a global diagnostic products company delivering solutions that build knowledge and understanding of complex clinical questions. Asuragen’s application of its deep scientific heritage and molecular expertise delivers diagnostic products in oncology and genetics that provide the best answers with optimal workflows – so time can be spent delivering actionable insights, rather than searching for them. With innovative approaches to kit development and a broad range of molecular chemistries, Asuragen produces assays that ensure reproducible results. From discovery and development to regulatory support to global commercialization, we also provide a tailored approach that efficiently delivers custom and companion diagnostic products for our partners. Asuragen is located in Austin, Texas, which is consistently ranked in the top 10 of “best places to live” list of US cities. Asuragen offers a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching contributions, employee stock option plan, and a tuition reimbursement plan.

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