Careers

OVERVIEW

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Looking for a great career that matters? Looking for an opportunity putting you on the front line of innovation in molecular diagnostics? What about a welcoming team? Sounds like you are looking for a career with NeuMoDx™ Molecular, a QIAGEN company. Whether you are a student, new grad, or an experienced professional consider a career with our team. Our career opportunities are listed below, if you do not see anything applying to your skill set – check back.

NeuMoDx™ is an Equal Opportunity Employer. We welcome and value the bringing together of diverse ideas and embrace a team culture that is accepting and understanding. Our team works to include individuals and companies that fit with that culture.
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Complaint Intake Specialist | Apply Now

NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Respiratory Infections, Sexually Transmitted and Infectious Diseases, NMDX has developed and commercialized a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.

Position: Complaint Intake Specialist – Ann Arbor, MI
Reports to: Field Service and Technical Support Manager
Location: Corporate office located in Ann Arbor, MI

Key Responsibilities:

  • Responsible for the product complaint intake and reporting process.
  • Receive complex medical information and ask probing questions to ensure the full picture of the complaint incidence is captured.
  • Evaluate event report to determine if it qualifies as a complaint.
  • Compile and organize complaint data and disseminate to Quality Affairs to aid in the analysis of customer complaint data to monitor and identify quality trends.
  • Work with Quality Engineers to ensure timely evaluation and completion of complaints.
  • Manage customer relationship and expectations during course of complaint investigation and resolution process.
  • Submit final complaint correspondence to the customer.
  • Obtain and submit complaint information to Regulatory Affairs based on FDA Medical Device Reporting and European Vigilance reporting requirements.
  • Maintain organized records following good documentation practices.
  • Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
  • Perform all other duties as assigned by Field Service and Technical Support Mange

Knowledge, Skills, and Abilities necessary to perform essential functions

  • Strong interpersonal and communication skills.
  • Ability to work independently and meet deadlines.
  • Ability to organize and handle high pressure situations.>
  • Demonstrated leadership abilities and decision-making abilities.>

Minimum Requirements/Qualifications:

  • Associate degree (minimum) required in a clinical, scientific, or healthcare related field.
  • Minimum two years work experience or relevant industry experience in medical device field
  • One or more years work experience with medical device complaint handling desired
  • Clinical laboratory and/or regulatory experience desired
  • Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
  • Must have experience communicating effectively with a wide variety of people.

NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.

For consideration, please submit resume along with salary requirements to sys-jobs@neumodx.com and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.

Commercial Program Manager | Apply Now

NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Respiratory Infections, Sexually Transmitted and Infectious Diseases, NMDX has developed and commercialized a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.

Position: Commercial Program Manager – Ann Arbor, MI
Reports to: Sr. Director, Marketing
Location: Corporate office located in Ann Arbor, MI

Key Responsibilities:
• Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
• Maintain employee training records.
• Lead all activities associated with Phase 5- Commercial Product Release including but not limited to:
◦ Labeling
◦ Translations
◦ Coordinating/monitoring cross-functional activities (V&V, RA, QA, Commercial)
◦ Coordinating launch activities/timelines with Commercial Partners
• Facilitate weekly cross-functional Commercialization Status meetings
• Facilitate Phase V Sign-off and Commercial Transfer meeting
Knowledge, Skills, and Abilities necessary to perform essential functions

• Understanding basic regulatory submission requirements /documents
• Understanding of basic QMS and engineering change release
• Understanding of good documentation practices/mgmt. /revision controls
• Understanding of change control requirements and assessment of design changes
• Basic knowledge of labeling requirement
• Critical thinking/problem-solving/organization skills
• Project management skills
• Work with technical information and subject matter experts to interpret technical requirements
• Ability to take inputs and translate to QMS/Regulatory requirements
• Ability to oversee multiple projects at various stages of completion
• Good communication skills and innate sense of urgency to drive project execution

Minimum Requirements/Qualifications:
• Technical Degree and/or related AA Degree or equivalent experience.
• Minimum two years technical experience or relevant industry experience labelling and commercialization.
• Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
• Proficiency with photo and design software and bar code software (i.e. Adobe Photoshop and BarTender)
• Proficient with Excel, MS Word, PowerPoint (MS office suite )

NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.
For consideration, please submit resume along with salary requirements to sys-jobs@neumodx.com and mention the job description in the subject. No phone calls please.  Only qualified candidates will be contacted.

Depot Repair Technician | Apply Now

NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories.  Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve.  In addition to focusing design and development efforts on tests to detect Respiratory Infections, Sexually Transmitted and Infectious Diseases, NMDX has developed and  commercialized a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.

Position: Depot Repair Technician – Ann Arbor, MI

Reports to: Field Service and Technical Support Manager

Location: Corporate office located in Ann Arbor, MI

Key Responsibilities:

  • Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
  • Maintain employee training records.
  • Repair and refurbish customer-returned modules and assemblies.
  • Communicate effectively with internal stakeholders the status of repairs and estimated time of completion.Provide feedback to factory personnel on product quality issues or improvements.
  • Maintain timely and accurate service records within ERP system including, but not limited to, closing service notifications, updating repair activities, inventory, labor, and printing customer facing documents.
  • Maintain company assets (Test equipment, tools, inventory, computer, etc.) in good and working condition.Assist with service and support for internal NeuMoDx molecular instruments.
  • Perform all other duties as assigned by Field Service and Technical Support Manger.

Knowledge, Skills, and Abilities necessary to perform essential functions

  • Proven ability to diagnose and resolve problems on sophisticated electronic, mechanical, and optical instrumentation maintained in a laboratory environment.
  • Strong interpersonal and communication skills.
  • Ability to work independently and meet deadlines.
  • Ability to organize and handle high pressure situations.
  • Demonstrated leadership abilities and decision-making abilities.
  • Experience with RT PCR technology is preferred.
  • Basic instructional abilities (training).

Minimum Requirements/Qualifications:

  • Technical Degree and/or related AA Degree or equivalent experience.
  • Minimum two years technical experience or relevant industry experience in electronic repair or equivalent experience.
  • Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
  • Familiarity with basic test equipment used in department (Multimeters, O’Scope, Pressure meters).
  • Ability to read, interpret and analyze component layout drawings, assembly drawings, wiring and labelling diagrams.
  • Must have experience communicating effectively with a wide variety of people.

NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.

For consideration, please submit resume along with salary requirements to sys-jobs@neumodx.com  and mention the job description in the subject.  No phone calls please.  Only qualified candidates will be contacted.

Clinical Research Associate | Apply Now

NeuMoDx Molecular Inc. is an innovative medical device company dedicated to developing vastly superior solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings. NeuMoDx is seeking a highly motivated individual to serve the role of a Clinical Research Associate (CRA) and be a key member assisting the clinical study team with all operational activities for new and on-going clinical research projects. The ideal candidate must be results oriented, demonstrate excellent interpersonal skills, and possess strong attention to detail in order to assist in the design, planning, and execution of molecular diagnostic product related clinical evaluations in accordance with all applicable regulations.

Responsibilities:

  • Ensure clinical research projects are conducted, recorded, and reported in accordance with approved protocols, FDA Regulations, ICH-GCP compliance, company SOPs and client guidelines
  • Effectively identify and liaise with physicians, investigators and study personnel conducting the trial to ensure effective execution of clinical study protocols
  • Conduct on-site visits and complete associated reports for site qualification, site initiation, interim monitoring and site closeout, which will include the following:
    • Train on-site personnel on the use of the NeuMoDx Systems and associated assays as well as study protocols, including CRF completion, event reporting, etc.
    • Perform source document verification where required, retrieve Case Report Forms (CRFs) and perform query resolution in a timely manner
    • Author, file, and collate study documentation, including all site correspondence, to compile the Trial Master File (TMF)
  • Identify, in a timely manner, issues that could potentially affect study results or on-time completion of the study, or any protocol deviation, and suggest means of resolving such issues
  • Assist in the development of the clinical research infrastructure including standard operating procedures, work instructions, templates and forms applicable to on-site visits
  • Support the compilation effort of clinical related data to the FDA and EU regulatory bodies

Experience and Qualifications:

  • Bachelor’s degree (minimum) required in a clinical, scientific, healthcare, or related field
  • A minimum of 3-5 years as a clinical research associate conducting on-site visits, preferably for in vitro diagnostic product evaluations. Will consider a work history involving IVD lab experience along with pharmaceutical or medical device field monitoring.
  • Working knowledge of GCP/ICH guidelines and FDA regulations
  • A sound understanding of statistics and clinical trial design is desirable
  • Can-do attitude with a willingness to go the extra mile to ensure project success with minimal oversight
  • Excellent written and verbal communication, as well as interpersonal skills – including negotiating and ability to build effective relationships with study site staff and colleagues
  • Exceptional organizational, planning, and administrative skills/eye for detail – responsibilities involve heavy documentation that must be accurate and thorough
  • Ability to prioritize, multi-task, problem solve and think on your feet in a fast-paced work environment
  • Working knowledge of molecular diagnostics is preferred
  • CRA or CRC certification preferred

In-house position with extensive travel (40-50%) required within U.S. and possibly internationally. Candidates must be able to work in the U.S. on an unrestricted basis and have a good driving record. Relocation package not available.

NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, life & disability insurance, and medical/dental plans.

For consideration, please submit resume along with salary requirements to jobs@neumodx.com and mention the job description in the subject.

Senior / Regulatory Labeling Specialist | Apply Now

NeuMoDx Molecular Inc. is an innovative medical device company dedicated to developing vastly superior solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings. NeuMoDx is seeking a Sr. / Regulatory Labeling Specialist responsible for all facets of product labeling, e-labeling, website and promotional materials, etc. This responsibility entails interpreting the medical device / in vitro diagnostic (IVD) regulations for product labeling, as well as the execution, management and tracking of requirements for all products, package inserts, labels and related items for the US as well as foreign markets.

Responsibilities:

  • Lead the regulatory review of all labeling based on the various domestic and international requirements – including product labels, instructions for use, e-labeling, website, advertising, and promotional materials
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements
  • Interpret, understand, and apply U.S. and international in vitro diagnostic (IVD) device regulatory requirements, statutes, regulations, policies and guidance documents to various projects
  • Manage the revision history of all product labeling and coordinate the translation of approved product labeling into the required languages of international markets while upholding all applicable requirements
  • Maintain product technical files for ongoing activities related to compliance with global directives and regulations.
  • Create and manage control of UDI requirements and listings.
  • Assist with the submission activities for a variety of in vitro diagnostic device regulatory approvals including CE mark, U.S. premarket approvals (PMAs), U.S. premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
  • Contribute to the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market surveillance activities in support of U.S. FDA and international regulatory submissions, as required
  • Lead the effort for creation of operating procedures and policy guidelines regarding US and CE-IVD labeling requirements
  • Perform other duties as required or assigned

Experience and Qualifications:

  • Bachelor’s degree required in a science, engineering or related technical field; advanced degree preferred.
  • Minimum 5 years of experience in regulatory labeling; IVD experience highly desired
  • Experience in medical device labeling, including Instructions For Use (IFUs), preferably IVD
  • Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferably for In Vitro Diagnostic Systems
  • Regulatory Affairs Certificate (RAC) preferred
  • Strong organizational skills, effective writing skills and meticulous attention to detail
  • Ability to work in a fast-paced/entrepreneurial team environment
  • High degree of initiative with the ability to work independently with minimal supervision
  • Ability to prepare and present concise information to groups
  • Experience working effectively in a cross-functional team setting
  • Ability to comprehend principles of engineering, physiology and medical device use
  • Capacity to plan and organize work while remaining flexible enough to handle multiple priorities

Candidates must be able to work in the U.S. on an unrestricted basis.

NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, and medical/dental plans. In-house position; relocation package not available.

For consideration, please submit resume along with salary requirements to jobs@neumodx.com and mention the job description in the subject.

Senior Regulatory Affairs Specialist | Apply Now

NeuMoDx Molecular Inc. (“NMDx”) is an innovative medical device company dedicated to developing vastly superior IVD solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings. The NeuMoDx Molecular System will offer improved ease of use, lower costs and higher performance as compared to any other random access, continuous loading system for nucleic acid testing.

A Senior Regulatory Specialist position is available immediately with NeuMoDx. As a member of the Regulatory and Clinical Affairs team, you will work on regulatory submissions with the FDA and EU as well as obtain international registrations for NeuMoDx IVD products. Leading efforts for product post-market surveillance and building NeuMoDx regulatory operations infrastructure are the primary responsibility of this position. Various other responsibilities include development of regulatory submission and compliance strategies as well as working with European Notified Bodies interactions for CE Marking requirements submissions and approvals. The individual in this position will play an important role in ensuring product labeling, which includes IFUs, SDSs and product labels, meets regulatory requirements for FDA and European Notified Bodies. The ideal candidate will have an excellent background in working and communicating with FDA and interpreting regulatory guidelines including FDA, cGMP, GLP, GCP, and ICH. 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:

  • Understand Post-Market Surveillance (PMS) requirements for medical devices (US and EU markets) and lead the effort to plan, implement and carry out the PMS system accordingly to ensure continued medical device safety.
  • Apply the PMS requirements to perform product vigilance and properly report incidents, field safety corrective actions (FSCAs) and recalls.
  • Interpret, understand, and apply U.S. and international in vitro diagnostic (IVD) device regulatory requirements, statutes, regulations, policies and guidance documents to various projects.
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic area and discipline relevant to assigned projects.
  • Lead submission activities for a variety of in vitro diagnostic device regulatory approvals including CE mark, U.S. premarket approvals (PMAs), U.S. premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
  • Maintain product technical files for ongoing activities related to compliance with global directives and regulations.
  • Contribute to the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market surveillance activities in support of U.S. FDA and international regulatory submissions, as required.
  • Support the regulatory review of labels, labeling, advertising and promotional materials.
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements.
  • Lead in the creation of operating procedures and policy guidelines.
  • May perform other duties as required or assigned.

Experience and Qualifications:

  • M.S. in Biochemistry, Microbiology, Molecular Biology or related field with at least 5 years of relevant work experience, ideally in the in-vitro diagnostic industry
  • Experience with regulatory submissions including 510(k) and PMA submissions.
  • Regulatory Affairs Certificate (RAC) is preferable
  • Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferably for Invitro Diagnostic Systems
  • Experience in medical device – preferably IVD – regulatory labeling, including Instructions For Use (IFUs) and product labels
  • Strong organizational skills, effective writing skills and meticulous attention to detail
  • Ability to work in a fast-paced/entrepreneurial team environment
  • High degree of initiative with the ability to work independently with minimal supervision
  • Ability to prepare and present concise information to group
  • Experience working effectively in a cross-functional team setting
  • Ability to comprehend principles of engineering, physiology and medical device use
  • Capacity to plan and organize work while remaining flexible enough to handle multiple priorities.

NMDx offers an entrepreneurial working environment, competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans. This is an in-house position. Relocation package not available.

For consideration, please submit resume along with salary requirements to jobs@neumodx.com and include the job description in the subject line. No phone calls please. Only qualified candidates will be contacted.

Field Service Engineer | Apply Now

Reports to: Service and Support Lead

Key Responsibilities

  • Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
  • Maintain employee training records.
  • Provide internal/external customer service by performing on-site service as required including break/fix, calibrations, preventive maintenance and other required services.
  • Repair and refurbish customer-returned modules and assemblies.
  • Communicate effectively with customers during all phases of service, including scheduling, diagnosis, quotation, and closeout.
  • Properly manage customer feedback and complaint process to ensure all information is captured and documented in a timely and concise manner.
  • Provide feedback to factory personnel on product quality issues or improvements.
  • Maintain timely and accurate service records within ERP system including, but not limited to, closing service notifications, updating repair activities, inventory, labor, and printing customer facing documents.
  • Maintains company assets (Test equipment, tools, inventory, computer, etc.) in good and working condition.
  • Assists with service and support for internal NeuMoDx molecular instruments.
  • Performs all other duties as assigned by Service and Support Lead Engineer.

Knowledge, Skills, and Abilities necessary to perform essential functions

  • Proven ability to diagnose and resolve problems on sophisticated electronic, mechanical and optical instrumentation maintained in a laboratory environment.
  • Must have strong interpersonal and communication skills.
  • Ability to work independently and meet deadlines.
  • Ability to organize and handle high pressure situations.
  • Demonstrated leadership abilities and decision-making abilities.
  • Experience with RT PCR technology is preferred.

Minimum Requirements/Qualifications

  • Technical Degree and/or related AA Degree or equivalent experience.
  • Minimum two years technical experience or relevant industry experience in electronic repair or equivalent experience.
  • Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
  • Familiarity with basic test equipment used in department (Multimeters, O’Scope, Pressure meters).
  • Ability to read, interpret and analyze component layout drawings, assembly drawings, wiring and labelling diagrams.

NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.

For consideration, please submit resume along with salary requirements to sys-jobs@neumodx.com  and mention the job description in the subject.  No phone calls please.  Only qualified candidates will be contacted.

Research Associate/Scientist (Assay Development) | Apply Now

Research associate/scientist positions are available immediately at the NeuMoDx. As a member of the assay development team you will be involved with all aspects of assay development, including assay design, reagent preparation, nucleic acid isolation and amplification, clinical sample testing, and assay verification. The ideal candidate will have familiarity with assay development; real-time PCR, nucleic acid purification; GLP and GMP concepts and the production of FDA approved IVD products. In addition to experience, an ability to 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 and validate novel nucleic acid preparation/purification strategies for implementation on the NeuMoDx proprietary platform
  • Implement and validate real-time PCR (and other amplification assays) for in-vitro diagnostic applications
  • Assist in the implementation of all bench-scale assays onto the NEUMODX systems as well as the transfer of developed assays from R&D to manufacturing
  • Participate in design and review meetings and critically evaluate design and/or implementation plans

Qualifications:

  • B.S or higher degree in Biochemistry, Microbiology, Molecular Biology or Biotechnology
  • 2–5 years of relevant work experience – ideally in the in-vitro diagnostic industry. Familiarity with GLP and GMP concepts
  • Hands-on experience with current nucleic acid isolation and purification strategies
  • Familiarity with design, development and validation of real-time PCR assays
  • Experience with handling pathogenic bacteria and clinical samples
  • Excellent written, verbal and analytical skills and the ability to thrive in a challenging, fast-paced multidisciplinary setting
  • Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation a must

NeuMoDx™ offers an entrepreneurial working environment and a competitive salary and benefits package featuring, disability insurance, flexible spending accounts and medical/dental plans.
For consideration, please submit resume along with salary requirements to jobs@neumodx.com and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.

** NeuMoDx™ is an Equal Opportunity Employer.

Manufacturing Specialist, Reagent | Apply Now

Reports to: Manager, Reagent Manufacturing

Summary

• Manufacturing Specialists are required to have a strong knowledge of manufacturing methods and techniques, process development experience, work flow understanding, ability to understand formulations and follow recipes and testing protocols for any in-process Quality checks
• In this position, Manufacturing Specialists, will maintain manufacturing equipment, create work instructions, train others, often be asked to contribute to or lead projects, be cross functionally trained to work in several areas as needed.
• This role requires a self-starter, ability to work independently, understanding of departmental goals-working as a team to achieve those goals within set timelines.

Role and Responsibilities

• Perform Reagent Assembly in accordance with Manufacturing Procedures (MPs), drawings and related Work Instructions (WKI).
• Prepare testing samples per Quality Testing (QT) procedures and instructions
• Carry out work in accordance with defined Quality Management System procedures, and support Quality initiatives.
• Support general Manufacturing objectives.
• Support systems development pilot production and experimental work orders, as required
• Assist in maintaining fixtures, assembly tools, assembly instrumentation and manufacturing job aids.
• Be committed to following and supporting safety practices.
• Prepares for production by reviewing work orders and production schedule, studying and clarifying specifications; calculating reagents and chemicals, as well as part requirements; collect materials and supplies. Set-up equipment necessary for different work orders.
• Documents production by completing applicable forms, reports, logs, and records equipment and batches using GDP practices.
• Keeps work areas clean and organized
• Contributes to Continuous Improvement efforts; Identify and help implement process, procedure, safety improvements.
• Complete and maintain training records within expected timelines.
• Maintain functional understanding of cGMP’s and the impact of deviation from controlled processes and/or procedures. Participate in investigations as needed.
• Train/mentor less experienced and new operators.
• Maintain inventory; be familiar with Kan Ban, and FIFO. May be required to complete inventory counts periodically.
• Completes other tasks as assigned.

Qualifications/Experience

• College Degree (BS/BA) in science or chemistry field plus 1 year relevant Lab or Reagent production work experience or an Associate’s degree and 2 years relevant work experience.

Applications Scientist | Apply Now

Summary

An Applications Scientist position is available immediately with NeuMoDxTM Molecular. As a key member of the commercial team, you will provide technical direction and support to customers on instrument operation, assay integration and maintenance of company products. Responsible for technical training, applications discussions, scientific exchanges, and troubleshooting/problem solving of customer issues. Scientifically support customers in implementing IVD products as well as transition of laboratory developed tests (LDTs) onto the NeuMoDxTM Systems. The ideal candidate will have excellent background in molecular biology/biochemistry as well as familiarity 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.

Key Responsibilities

  • Demonstrate the use of and train current and potential customers on NeuMoDxTM Molecular Systems, software, reagents.
  • Continuously monitor customer satisfaction and initiate activities for continual improvement.
  • Rapidly respond to external customer scientific inquiries via multiple channels and participate in scientific exchange to discuss assay applications, diagnose issues, suggest troubleshooting solutions.
  • For LDT customers, assist in the migration of bench-scale techniques into fully automated procedures run on the NeuMoDxTM Systems.
  • Identify, confirm, and interpret instrument performance issues related to integration of individual assays; communicate issues cross-functionally and provide suggestions, solutions, and/or test plans for resolution.
  • Recognize and communicate trends in product issues and their impacts on customers, serving as the voice of the customer to communicate product use/preferences ensuring continuous improvement in product design and usability.
  • Maintain documentation of scientific exchanges, record analyses and interpretation of experimental data and produce required training and educational material.

Qualifications

  • B.S. in Biochemistry, Microbiology, Molecular Biology or related field with 3-6 years of relevant work experience. Previous customer-facing experience in a service/support function is highly desired.
  • Extensive experience with current nucleic acid isolation and purification techniques from a variety of clinical specimens and pathogenic organisms.
  • Must be able to travel up to ~40%.
  • Adaptability to work within new environments, cultures, processes and clinical settings and under strict deadlines.
  • Demonstrated problem solving skills to understand and solve complex, interrelated issues between assay chemistry, reagents, consumables, hardware, and software.
  • Excellent written, verbal and analytical skills with proficiency in the use of MS Office Suite for data analysis, documentation, and presentation.
  • Familiarity with GLP, ISO, and QSR requirements for IVD products.

NeuMoDxTM offers an entrepreneurial working environment and a competitive salary and benefits package featuring stock options, paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.

For consideration, please submit resume along with salary requirements to careers@neumodx.com  and mention the job description in the subject.  No phone calls please.  Only qualified candidates will be contacted.

Assay Integration Scientist | Apply Now

Summary

An Assay Integration Scientist position is available immediately with NeuMoDx™. As a member of the Assay 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 a complete clinical diagnostic system. 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.

Position 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.
  • 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.
  • 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.

Essential Knowledge and Skills

  • B.S or M.S. in Biochemistry, Microbiology, Molecular Biology or related field with at least 2 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 procedures and/or instrumentation.
  • Experience handling a variety of clinical specimens and pathogenic organisms.
  • Excellent written, verbal and analytical skills.
  • 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.

Experience

  • Nucleic Acid Extraction: 1 year (Required)
  • Assay Development: 2 years (Required)
  • PCR: 2 years (Required)

Education

  • Bachelor’s (Required)

Work authorization

  • United States (Required)

Required travel

  • 25% (Preferred)

Research Associate / Scientist | Apply Now

Research assistant/associate/scientist positions are available immediately at the NeuMoDx™. As a member of the assay development team you will be involved with all aspects of assay development, including assay design, reagent preparation, nucleic acid isolation and amplification, clinical sample testing, and assay verification. The ideal candidate will have familiarity with assay development; real-time PCR, nucleic acid purification; GLP and GMP concepts and the production of FDA approved IVD products. In addition to experience, an ability to 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 and validate novel nucleic acid preparation/purification strategies for implementation on the NeuMoDx™ proprietary platform
• Implement and validate real-time PCR (and other amplification assays) for in-vitro diagnostic applications
• Assist in the implementation of all bench-scale assays onto the NeuMoDx™ systems as well as the transfer of developed assays from R&D to manufacturing
• Participate in design and review meetings and critically evaluate design and/or implementation plans

Qualifications:

• B.S/M.S in Biochemistry, Microbiology or Molecular Biology
• 3–5 years of relevant work experience – ideally in the in-vitro diagnostic industry. Familiarity with GLP and GMP concepts
• Hands-on experience with current nucleic acid isolation and purification strategies
• Familiarity with design, development and validation of real-time PCR assays
• Experience with handling pathogenic bacteria and clinical samples
• Excellent written, verbal and analytical skills and the ability to thrive in a challenging, fast-paced multidisciplinary setting
• Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation a must

NeuMoDx™ offers an entrepreneurial working environment and a competitive salary and benefits package featuring, disability insurance, flexible spending accounts and medical/dental plans.
For consideration, please submit resume along with salary requirements to careers@neumodx.com and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.

** NeuMoDx™ is an Equal Opportunity Employer.
Location: Ann Arbor, MI Start Date: Early 2018.
The information contained herein is not intended to be an exhaustive list of all responsibilities and qualifications required of individuals performing the job. The qualifications detailed in this job description are not considered the minimum requirements necessary to perform the job, but rather as guidelines.  An Equal Opportunity Employer, NeuMoDx™ requires a diversity of people, perspectives and ideas to address the complex challenges of its business.  NeuMoDx™ is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sex, age, sexual orientation, gender identity, status as a protected veteran, or status as a qualified individual with a disability.

GENERAL INQUIRIES

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    IMPORTANT ANNOUNCEMENT

    We are excited to announce that QIAGEN has acquired all shares of NeuMoDx Molecular, Inc. The addition of NeuMoDx’s medium- and high-throughput molecular systems further expands QIAGEN’s portfolio of molecular diagnostics instruments, bolstering our leadership in automated molecular testing. We are proud to welcome NeuMoDx to our family of PCR solutions that make improvements in life possible.

    To learn more, click here.