Senior Scientist/Scientist Systems Integration

Company: QIAGEN
Location: Ann Arbor
Posted on: January 21, 2023

Job Description:

OverviewAt the heart of QIAGEN's business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees - more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
Position DescriptionA Senior Scientist/ Scientist Systems Integration position is available immediately in the assay Systems Integration group. As a member of the Systems Integration team, you will work cross-functionally to solve critical problems associated with the integration of individual molecular assays, hardware modules, and software components onto the NeuMoDx Molecular Diagnostic Systems. Specific responsibilities will include development and execution of test protocols and verification/validation tests to evaluate and troubleshoot the performance of complex interactions between nucleic acid extraction methods from multiple clinical matrices, real-time PCR amplification and detection, and mechatronic modules - including thermal control modules, fluorescence detection modules, precision motion control elements and advanced liquid handling systems. The ideal candidate will have excellent background in molecular biology/biochemistry as well as moderate experience with the testing and integration of complex systems. We are looking for a well-rounded candidate with a knack for problem solving in both team and independent settings to ensure the completion of aggressive project timelines.
Responsibilities

• Independently design, execute and troubleshoot nucleic acid purification, PCR amplification and real-time detection experiments.
• Migrate bench-scale techniques into fully automated procedures run on the NeuMoDx platform, incorporating the assay chemistry, individual modules, liquid handling, and software interface.
• Design, develop and execute test procedures for integration, validation and verification studies.
• Critically analyze and interpret data. Maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO 13485 compliance, GLP/GMP requirements, IVDR, etc.).
• Identify, confirm, and interpret instrument performance issues related to integration of individual assays and mechanical modules. Communicate issues cross-functionally and provide suggestions, solutions, and/or test plans for resolution.
• Participate in design review meetings and critically evaluate design and/or implementation plans.
• Support FDA and CE-IVD submissions and responses, working within the quality design control process.
• Understand the requirements of the end-user and provide feedback regarding process or system improvements accordingly.
• Maintain accurate data records, test plans, and reports. Clearly summarize and present information to senior management and other personnel both internally and externally as required.
• Comply with document control procedures and maintain the effectiveness of the quality system.
• Comply with biohazard safety standards through proper handling of potentially infectious biological agents and other hazardous chemical materials.
  Position Requirements
  Qualifications:
  • BS or M.S. in Biochemistry, Microbiology, Molecular Biology or related field with at least 3-5 years of relevant work experience, ideally in the in-vitro diagnostic industry.
  • Hands-on experience with current nucleic acid isolation and purification strategies.
  • Familiarity with design, development, verification and validation of molecular assays and instrumentation.
  • Excellent project management skills. Strong analytical and organizational skills exemplified by clear oral presentations and written documentation.
  • Experience and willingness to handle a variety of clinical specimens and pathogenic organisms.
  • Ability to thrive in a challenging, fast-paced multidisciplinary setting.
  • Demonstrated problem solving skills to understand and solve complex, interrelated issues between assay chemistry, reagents, consumables, hardware, and software.
  • Strong proficiency in the use of MS Office Suite for data analysis and presentation; basic statistics knowledge is highly desired
  • Knowledge of GLP, ISO, and QSR requirements for IVD products preferred.
    Personal Requirements
    • Ability to work flexibly, under pressure and tight timelines.
    • Team player with enthusiasm, leadership skills, pragmatism and resilience.
    • Concern for regulation and quality.
    • Excellent organizational, communication and interpersonal skills, fluent in English language.
      QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact Benefits@QIAGEN.com. This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.
      What we offerAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
      QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Keywords: QIAGEN, Ann Arbor , Senior Scientist/Scientist Systems Integration, Other , Ann Arbor, Michigan