Senior Scientist I - Product Development

Organization
Asuragen
Job Location
2150 Woodward Street
Suite 100
Austin, TX 78744
Job Description

Asuragen is seeking an outstanding Ph.D.-level scientist who can work independently and as part of a Product Development group that is responsible for optimizing, verifying and validating assays for the detection and quantification of nucleic acid biomarkers. This high-impact position will help expand Asuragen’s molecular diagnostics portfolio that currently influences over 15 million patient management decisions each year.

The Product Development Senior Scientist position combines strong technical know-how about amplification technologies with Design Control process and regulatory compliance to guide development of diagnostic systems that integrate reagents, instruments and software. Working as part of a cross-functional team, this role is expected to receive prototype assays from Asuragen’s Research group and then achieve verified and/or analytically validated products through carefully designed and documented internal and external studies. Key responsibilities include developing assay design inputs/outputs, determining assay failure modes, setting data-driven performance specifications, and designing, executing and interpreting studies that address assay accuracy, precision, analytical sensitivity and specificity, and other relevant verification or validation activities, while documenting results consistent with FDA and international regulatory requirements. Successful candidates will join a fast-growing company of nearly 160 employees focused on enhancing patient care through the development of cutting-edge diagnostic assays in disease areas spanning genetic disorders and cancer.

Qualifications

  • A Ph.D. degree in molecular biology, chemistry, biomedical engineering, or related field
  • Expertise in developing and optimizing multiplexed PCR-based assays
  • Working knowledge and demonstrated application of CLSI, ISO and FDA guidelines and regulations for product development under Design Control
  • Ability to analyze complex data with relevant statistical methods and clearly communicate to technical and non-technical audiences
  • Ability to drive successful project outcomes through intra- and inter-department collaborations
  • Ability to assimilate information from multiple sources and present clear and specific recommendations to management and project teams
  • Ability to establish and maintain external relationships with key opinion leaders and/or subject matter experts
  • Excellent written and verbal communication skills
  • A passion for improving patient care through diagnostic technologies, particularly in genetics and oncology
Requirements
  • 2-4+ years post-Ph.D. industry relevant experience
  • Experience in developing regulated molecular diagnostic tests, especially FDA-cleared or -approved tests
  • Expertise in developing high plexity DNA or RNA PCR assays for use with samples such as blood or FFPE tissue, especially those that can detect SNP/SNV, indel, and/or CNV markers
  • Expertise with capillary electrophoresis and/or qPCR instrumentation
  • Effective management of one or more junior scientists
  • Prior experience with developing products within a formalized project management structure
  • Experience in initiating and managing process improvement initiatives in a regulated environment