Diagnostic Research Scientist

Job Location
Middleton, WI
Commensurate upon experience.
Job Description

This position will plan, design and conduct laboratory analytic studies with minimal supervision. It will serves as an addition to the current diagnostic product development team. This position will also provide support to the development team through participation in discussions and drafting of FDA submission packages.



  • Plan, design and conduct laboratory analytic studies with minimal supervision.


  • Analyze and present data to peers and managers.


  • Provide regular reports to Manager and Team on project progress, risks to completing objectives and plans to mitigate risks.


  • Support development and editing of elements of FDA submission packages.


  • Conduct their work in accordance with established safety and quality system rules.


  • Perform experiments using pathogenic bacterial and viral strains in a BSL-2 lab, with proper training and equipment.


  • Perform experiments using clinical specimens in a BSL-2 lab.



  • Serve as a back up to other development team members as the need arises.


  • Assist in ordering, lab maintenance and other general activities related to operating a research and development laboratory environment.


  • BS or BA (MS or Ph.D. preferred) degree in a life-sciences related discipline.


  • Strong technical skills and demonstrated experience with molecular biology methods such as nucleic acid purification, amplification and detection, assay development, troubleshooting and optimization.


  • Strong medical device product development skills such as reagent development and optimization, assay protocol optimization following DOE principles, migration of manual assays to an automated device, specifications development, statistical analysis, verification, manufacturing and validation protocol writing.


  • Minimum of 3 years lab experience with proven knowledge of regulated product development.


  • Experience working under ISO or similar quality system.


  • Ability to work independently as well as a member of a team.


  • Flexibility to change roles or participation as conditions warrant.


  • Ability to display excellent written and oral presentation and communication skills.


  • Strong commitment to timelines and deliverables.


  • Highly driven, with strong internal motivations to succeed.


  • Has approachable manner that encourages interactions.


  • Knowledge of Microsoft Office (Word, Excel, Power Point, Outlook), data analysis software and use of internet resources.



  • Experience in real time PCR, qPCR, RT-PCR and LAMP.


  • Experience of working in BSL-2 environment and with a variety of clinical specimens.


  • Previous experience with in vitro diagnostic product development.


  • Previous experiences with writing protocols and reports for FDA 510(k) submissions, validation master plans and design history files.


  • Experience working in medical device industry under ISO 13485 quality system.


  • Experience managing scientific collaborations.


  • Experience giving oral presentations, teach or training other scientists.


  • Well organized, able to devise and manage processes for staying organized.



  • Able to move up to 40 lbs.
  • Able to use computer and telephone equipment.
  • Stand or sit for extended periods of time.


Lucigen Corporation is an Affirmative Action/Equal Opportunity Employer.

How to Apply

Interested candidates should submit their resume to hr@lucigen.com with "Diagnostic Research Scientist" in the subject line.

About Our Organization

Lucigen was founded in 1998 by David Mead, Ph.D., focusing on the development of life science research products and technologies for genetic cloning. Lucigen offers solutions to current problems in DNA cloning, sequencing, amplification, and protein expression by providing exceptionally reliable products and services to life science researchers in an ISO 13485 compliant environment. Lucigen is a recognized leader in NGS library construction and the only commercial source for mate pair libraries greater than 10 kb. The Company also offers a wide range of NGS services to researchers looking to extract critical information from their human, animal, plant, or microbial genomes.

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