Associate Director

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.

As the leader of the assay verification and validation (V&V) group you will be a key contributor to product development, leading a team of 10 scientists focused on V&V-related activities on the NeuMoDx Molecular Systems as required by CE-IVD, FDA, and international regulatory agencies. The ideal candidate will have in-depth experience in assay development, real-time & multiplex PCR, nucleic acid purification, automated molecular diagnostic systems, and verification and validation testing. The candidate must be an enthusiastic, motivational leader who interacts well across departments to meet project timelines.

RESPONSIBLITIES:

• Direct team of scientific associates, including training, project activities, goal setting, and career development
• Manage the integration and verification and validation of assays over a variety of specimen types (e.g., urine, swab, blood, plasma) on the NeuMoDx Molecular Systems through requirements definition, development, execution, data analysis, and review of V&V studies.
• Support FDA and CE-IVD submissions and responses, working within the quality design control process.
• Participate in design review meetings and support risk management activities.
• Identify, interpret, and troubleshoot instrument performance issues related to integration of individual assays and electromechanical modules.
• Organize weekly team meetings, as well as present data at cross-functional group meetings.

• MS or PhD in Biochemistry, Microbiology, or Molecular Biology with at least 10 years of relevant experience in the in-vitro diagnostic industry.
• Hands-on experience with current nucleic acid isolation and purification strategies. Experience with automated molecular diagnostic platforms strongly preferred.
• Thorough knowledge of design, development, verification, and validation of real-time PCR assays.
• Excellent written, verbal, and analytical skills
• Proven record of project and people management skills. Strong analytical and organizational abilities exemplified by clear oral presentations and technical writing.
• Ability to identify, understand and solve complex issues between specimen, 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

• Ability to work flexibly, under pressure and tight timelines, and thrive in a challenging, fast-paced multidisciplinary setting.
• 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.

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.