Senior Scientist/ Scientist Systems Integration
Company: QIAGEN
Location: Ann Arbor
Posted on: August 4, 2022
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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
RequirementsQualifications: 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 BenefitsQIAGEN.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.PDN-964932ec-9419-4031-94e3-5f8efd3fb4d7
Keywords: QIAGEN, Ann Arbor , Senior Scientist/ Scientist Systems Integration, Other , Ann Arbor, Michigan
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