Scientist at QIAGEN in Ann Arbor, Michigan

Job Description:

Overview

At 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 Description

As a member of the Assay Development team, you will be involved product development, including assay design, reagent preparation, nucleic acid isolation and amplification, clinical sample testing, and assay verification. The ideal candidate will have extensive experience in product development under design control; real-time PCR, nucleic acid purification; thorough understanding in GLP and GMP concepts, IVD regulations and quality controls. In addition to experience, an ability to work independently, think 'outside of the box' and create novel solutions to challenging problems and at the same time adhering to established lab protocols strictly is very much desired. Although, the successful candidate must work well in team settings, s/he must be able to work independently to assure the completion of project timelines.

Responsibilities

• Develop, optimize, troubleshoot, and validate in vitro molecular diagnostic products, including nucleic acid preparation/purification and real-time PCR.


• Working in a design control environment, participate in design and review meetings and critically evaluate design and/or implementation plans. Provide scientific expertise, and project management skills to execute product development strategies to ensure product design and development documentation and processes adhere to FDA (510(k) and PMA), CE-IVD, and other regulatory agency requirements. Anticipate potential problems and design preventative solutions. Determine strategic approach to experimental design.

• 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.).

• Assist in the implementation of all bench-scale assays onto the NeuMoDx systems as well as transfer of developed assays from R&D to manufacturing

Position Requirements

Qualifications:

• M.S or higher degree in Biochemistry, Microbiology, Molecular Biology or related discipline.


• 5-7 years of relevant work experience - ideally in the in-vitro diagnostic industry, assay development in molecular diagnostics or closely related field.

• Extensive understanding of molecular biology techniques, current nucleic acid isolation and purification strategies.

• Extensive experience with design, development and validation of real-time PCR assays


• Good understanding of industry standards and regulations


• Project management skills. Strong analytical and organizational skills exemplified by clear oral presentations and written documentation.

• Proven to work well and thrive in a challenging, fast-paced multidisciplinary setting

Personal Requirements

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 offer

At 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.

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