ArcherDX Careers In Boulder
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RA/QA Project Manager (ADX-139-20)

ArcherDX
Greater Boulder Area
2 days ago
+32
The RAQA Project Manager will identify, organize and drive key initiatives within the quality domain. This role will help enable best-in-class performance from Archer’s quality & regulatory teams by tracking key deliverables, communicating priorities and anticipating obstacles. This position will complement the quality team’s skills with sharp organizational communication, planning, and transparency.

Principal Scientist/ IVD Manager - IVD/CDx Assay Development A(ADX-192-20)

ArcherDX
Greater Boulder Area
4 days ago
+32
Will work closely with R&D, Quality, Regulatory, Clinical Development, Production teams and external pharma partner to translate laboratory processes from feasibility to validated assay. Additionally, will work closely with the Marketing, Medical, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong leadership and multi-disciplinary skills including expertise in biochemistry/molecular biology, technology, analytical validation including study design and interpretation of data, and excellent written and oral communication.

Senior Scientist - IVD/CDx Assay Development (ADX-193-20)

ArcherDX
Greater Boulder Area
4 days ago
+32
Will work closely with R&D, Quality, Regulatory, Clinical, and Production teams to translate laboratory processes from feasibility to validated assay. Additionally, will work closely with the Marketing, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong multi-discipline skills from technical, to writing, to communication.

Quality Engineer (I/II) (ADX-172-20)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Quality Engineer, reporting to the Sr. Quality Engineer/Manager Quality Engineering, will implement the Quality Management System (QMS) to ensure in-vitro diagnostic (IVD) medical devices manufactured under Good Manufacturing Practices are in compliance with relevant ISO standards and FDA regulations. The Quality Engineer will also be tasked with understanding the underlying quality issues and implementing continuous improvement activities to ensure that standards are maintained.

Sr. Manager - International Regulatory Affairs and Vigilance Reporting (ADX-180-20)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Sr. Manager, International Regulatory Affairs and Vigilance Reporting will be responsible for managing relationships with foreign regulatory agents and seeing international submissions for genomic devices and IVDs including companion diagnostics to a successful conclusion. For globally marketed products, this position will oversee ongoing complaint and vigilance reporting to health authorities around the world, including the USA.

Global Product Manager - IVD (ADX-194-20)

ArcherDX
Greater Boulder Area
5 days ago
+32
Are you passionate about precision oncology and improving patient access to personalized molecular detection tools that can be used in local settings? As an IVD Product Manager you will be responsible for bringing new IVD products through the R&D and regulatory review processes and supporting their launch and commercialization. You will orchestrate and lead a collaborative planning process to define and execute the IVD assay strategy to support the Company’s commercial business goals. This role will have responsibility for managing successful IVD launches providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of clinical molecular testing for solid tumors and heme malignancies. As the product owner, you will interact with other departments including R&D, Project Management, Regulatory Affairs, Quality, Market Access, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products successfully enter into the market and that budgets, timelines and performance objectives are met.

Process Automation Engineer (ADX-192-20)

ArcherDX
Greater Boulder Area
5 days ago
+32
We are looking for a driven and talented Process Automation Engineer to join the Assay Manufacturing group at ArcherDX. The Assay Manufacturing group is responsible for making rapid and high-quality assays utilizing our Anchored Multiplex PCR (AMP™) technology for use in oncology, immunology, and constitutional genomics. The Process Automation Engineer is responsible for implementing, maintaining, and enhancing robotic systems to enable high-throughput, high-quality production of both standard and custom NGS screening panels and components. The ideal candidate will have prior experience in a cGMP-regulated environment using and administering electronic systems and controls. This role will require cross-functional leadership skills in order to develop, implement, and optimize automated manufacturing solutions.

Clinical Research Associate (ADX-186-20)

ArcherDX
Greater Boulder Area
6 days ago
+32
ArcherDX has an openings for a Clinical Research Associate to join the Clinical Development and Operations team. Responsible for the conduct of clinical study activities to verify and validate new iassays developed by ArcherDX. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

Global Product Manager - IVD (ADX-190-20)

ArcherDX
Greater Boulder Area
6 days ago
+32
Are you passionate about precision oncology and improving patient access to personalized molecular detection tools that can be used in local settings? As an IVD Product Manager you will be responsible for bringing new IVD products through the R&D and regulatory review processes and supporting their launch and commercialization. You will orchestrate and lead a collaborative planning process to define and execute the IVD assay strategy to support the Company’s commercial business goals. This role will have responsibility for managing successful IVD launches providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of clinical molecular testing for solid tumors and heme malignancies. As the product owner, you will interact with other departments including R&D, Project Management, Regulatory Affairs, Quality, Market Access, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products successfully enter into the market and that budgets, timelines and performance objectives are met.

Global Product Manager - RUO Assays (ADX-191-20)

ArcherDX
Greater Boulder Area
6 days ago
+32
Are you passionate about precision oncology and improving patient access to personalized molecular detection tools that can be used in local settings? As an RUO Product Manager you will be responsible for bringing new research use products through development and supporting their launch and commercialization. You will orchestrate and lead a collaborative planning process to define and execute the RUO assay strategy to support the Company’s commercial business goals. This role will have responsibility for managing successful RUO launches providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of products designed to accelerate oncology research. As the product owner, you will interact with other departments including R&D, Sales, Project Management, Quality, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products successfully enter into the market and that budgets, timelines and performance objectives are met.

Project Manager - IVD (ADX-184-20)

ArcherDX
Greater Boulder Area
6 days ago
+32
The Project Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will centrally manage one or more projects and apply project management knowledge, skills, tools, and techniques to project activities to meet project requirements and achieve desired outcomes. The selected candidate will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, and closing under the leadership directive of the General Manager and Program Manager. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.

Clinical Study/Research Manager (ADX-181-20)

ArcherDX
Greater Boulder Area
6 days ago
+32
ArcherDX is hiring a Clinical Study Manager to help lead clinical trials in the Clinical Development and Operations Department. You will be responsible for the day-to-day management of clinical trials and will manage the study team, vendors, clinical monitors, and clinical trial sites. This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. Will be a key member of the Clinical Development and Operations team and responsible for ensuring the achievement of own or others’ project goals and objectives. This person may have line management responsibilities.

Test Engineer I/II/III - Medical Device Software (ADX-183-20)

ArcherDX
Greater Boulder Area
1 week ago
+32
Test Engineer I/II/III - Medical Device Software (ADX-183-20)   Company Summary: ArcherDX, Inc., creates catalog and custom next-generation sequencing (NGS) assays that are purpose-built to identify mutations and gene fusions from clinical sample types. By combining novel enrichment chemistry, automated informatics and a user-friendly workflow, Archer™ products remove the bottlenecks associated with using next-gen sequencing in a translational

Software Engineer in Test II/III (ADX-182-20)

ArcherDX
Greater Denver Area
1 week ago
+32
Software Engineer in Test II/III (ADX-182-20)   THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com   ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX

IDN//GPO Business Development Executive - West (ADX-162-20)

ArcherDX
Greater Denver Area
2 weeks ago
+32
The focus of the IDN/GPO Business Development Executive (BDE) is to lead the development of business and engagement strategies across strategically focused health system IDNs, Group Purchasing Organizations (GPOs) and physician aggregation groups. You will directly work with c-suite leaders and drive company goals at the highest levels of named IDN/GPOs to identify new sales opportunities, build and foster relationships and effectively negotiate system-wide contracts for our IVD and RUO products. To ensure alignment in messaging across our company portfolio and value proposition in an integrated manner, the role will also serve as a liaison between health systems, sales and national accounts, and channel partnerships.

Quality Control Associate I/II/III, IVD (ADX-170-20)

ArcherDX
Greater Boulder Area
2 weeks ago
+32
Executes test methods to evaluate quality, functionality and stability of raw materials, in-process materials and finished products to ensure that they are in compliance with specifications for use in Good Manufacturing Practice (GMP) applications for In-Vitro Diagnostics (IVD). Tracks and identifies trends in QC data and recommends corrective actions when necessary. Assists in method transfer, method validation and method troubleshooting activities. Conducts out-of-specification (OOS)/ out-of-trend (OOT) investigations as needed. Lead and support process improvement projects within all QC laboratories ensuring harmonization between the three labs. This position reports to the QC Supervisor, IVD.

Director of Manufacturing Quality Operations (ADX-173-20)

ArcherDX
Greater Boulder Area
2 weeks ago
+32
The Director of Manufacturing Quality Operations will establish, oversee, and manage the Manufacturing Quality and Continuous Improvement programs. S/he will provide leadership to establish and maintain quality levels that meet and exceed customer expectations. The Director of Manufacturing Quality Operations will implement and maintain a statistical based quality system, develop and maintain manufacturing quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships. Function includes management and oversight over Purchasing and Manufacturing Quality Department; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that Purchasing / Manufacturing QA department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.

Facilities Technician (ADX-178-20)

ArcherDX
Greater Boulder Area
2 weeks ago
+32
Facilities Technician (ADX-178-20)   THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com   ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides

Director, Pharma CDx Business Development, East or West (ADX-169-20)

ArcherDX
Greater Denver Area
2 weeks ago
+32
The successful candidate brings to this role proven sales/consulting and business development experience, the ability to coordinate multi-disciplinary teams, as well as technical and commercial perspective on Pharmaceutical sponsored clinical trials and processes. This position will be responsible for managing major Pharma to define specific product requirements in various stages of Drug Development and managing relationships with key ArcherDX collaborating partners. They will also be responsible for managing ArcherDX products and services for the Pharma accounts within the territory, maximizing customer value and satisfaction by aligning complex product solutions and services with key customer initiatives, building and maintaining relationship with key decision makers or potential influencers, as well as selling the emerging regulated clinical technologies portfolio specific to clinical trial markets within a designated territory resulting in executed contracts to support CDx and non-CDx opportunities. 

Director of Clinical Software Engineering (ADX-158-20)

ArcherDX
Greater Boulder Area
2 weeks ago
+32
As the Director of Clinical Engineering, you will lead the development of our clinical products that are will be approved by regulatory authorities and used to diagnosis and provide treatment paths for patients around the world.

Project Manager - IVD (ADX-156-20)

ArcherDX
Greater Boulder Area
2 weeks ago
As a Program Manager you will be responsible for bringing new IVD products through the product development process. You will orchestrate and lead collaborative planning to define and execute product development processes to support the Company’s commercial business goals. This role will have responsibility for managing program timelines, identifying key risks and mitigations, and facilitating execution of program goals. As the program lead, you will interact with other departments including R&D, Marketing, Regulatory Affairs, Quality, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products are successfully launched, and that timelines and performance objectives are met.

DevOps Group Lead (ADX-160-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The DevOps Group Lead position is responsible for a variety of process and infrastructure initiatives, including development and enhancements for Archer’s flagship cloud-based genomics product, automating platforms supporting regulatory initiatives, enhancing existing pipelines to improve efficiency and long-term ecosystem health, and developing new processes to enable telemetry, actionable alerts, and self-healing infrastructure. This position will supervise a small team of DevOps engineers.

Technical Writer (ADX-159-20)

ArcherDX
Greater Boulder Area
2 weeks ago
We are seeking a talented Technical Writer to join our expanding team. The successful applicant will be responsible for creating technical documents and manuals, explain complex information in a clear and concise manner and working with technical staff to ensure accuracy of product descriptions. You will be working alongside a talented group of software and DevOps engineers to document new and existing processes, help the team organize and centralize all documentation efforts, and help create process documentation and work instruction for the team to follow.

IS Security Analyst (ADX-148-20)

ArcherDX
Greater Boulder Area
2 weeks ago
This successful candidate will be tasked to ensure the company wide IT infrastructure and its data are being operated, maintained, and disposed of in accordance with IT security policies & procedures outlined in the organizational IT Security and Data Privacy program. They will work alongside Senior level IT Security/Infrastructure personnel as well as Legal, Quality, Compliance and Regulatory teams to ensure the IT Security and Data Privacy programs are successfully managed as the company evolves/grows.

Site Reliability Engineer (ADX-155-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Site Reliability Engineer position is responsible for a variety of process and infrastructure initiatives, including platform maintenance and enhancements for Archer’s flagship cloud-based genomics product, automating existing pipelines to improve efficiency and long-term ecosystem health, performing software updates across our AWS platform, and ensuring that managed assets are performing as expected through the use of telemetry, automated alerts, and self-healing infrastructure.

Project Manager (ADX-143-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Project Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will centrally manage one or more projects and apply project management knowledge, skills, tools, and techniques to project activities to meet project requirements and achieve desired outcomes. The selected candidate will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, and closing under the leadership directive of the General Manager and Portfolio Manager. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.

Process Quality Engineer II/III (PCM) (ADX-131-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Process Quality Engineer II/III, reporting to the Senior Quality Engineer, will support tech transfer, production scale-up, and Quality operations activities for Personalized Cancer Monitoring (PCM) product development, and implement the Quality Management System (QMS) to ensure ArcherDX medical devices are manufactured under FDA GMP and ISO 13485 regulations. The Process Quality Engineer II/III will also be tasked with developing quality processes in a high-throughput Manufacturing environment, investigating quality issues, and implementing continuous improvement activities to ensure that production rates are scalable while maintaining Quality standards.

Software Support Engineer (ADX-100-20)

ArcherDX
Greater Denver Area
2 weeks ago
The Software Support Engineer is responsible for supporting ArcherDx’s core software products, including Archer Analysis, and other products and services as required. The ideal candidate will possess a solid background in software infrastructure (e.g. virtual environments, cloud computing, containers, and other solutions related to enterprise-class software hosting), as well as demonstrable experience troubleshooting technical issues. He/she should be able to work with basic Python and Bash, be proficient in working on the Linux command line, the AWS console, and have familiarity with VMware based hypervisors. Finally, this position will be customer facing: Candidates should be personable and excited to work with our clients to answer questions and help resolve issues.

DevOps Engineer (ADX-09-20)

ArcherDX
Greater Boulder Area
2 weeks ago
DevOps Engineer (ADX-09-20)   p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'}p.p2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'; min-height: 14.0px} THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com   ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an

Software Engineer III/IV (ADX-126-20)

ArcherDX
Greater Denver Area
2 weeks ago
The primary role of this position is to contribute high quality and well-tested code to an existing set of bioinformatics data processing workflows, as well as triage reported issues in the current and previous versions of the processing software. Implemented code will either be conversions of R&D experimental code or novel code created to specifications. Through the development of both research use and clinically validated software this position will contribute heavily to the development of the next generation of Archer Analysis algorithms and implementations. The vast majority of the code that we write is in Python, although time critical processing is performed in C++.

Validation Manager (ADX-127-20)

ArcherDX
Greater Boulder Area
2 weeks ago
This position is responsible for the Management of Validation activities for in-Vitro Diagnostics Manufacturing and related support functions. Maintains and develops a team-oriented Validation workforce. Works with outside entities to complete Validation activities as they relate to ArcherDx, Inc. Cultivates a dedicated team within a fast-paced and growing environment. Builds documentation and process for IVD manufacturing and distribution and maintains/improves systems based on relevant changes in industry.

Software Engineer in Test II/III (ADX-125-20)

ArcherDX
Greater Denver Area
2 weeks ago
Software Engineers in Test build tools and test cases to verify software used in next-generation sequencing. They apply software engineering and computer science techniques to the unique problems of software testing. You will be working on a day to day basis with a team of software engineers and technical product managers defining and updating software requirements and design and translating them into automated tests. You will be responsible for writing, reviewing, updating regulated documents. As required, you will build test harnesses and other testing tools to accelerate testing.

Senior Software Engineer (ADX-117-20)

ArcherDX
Greater Denver Area
2 weeks ago
The challenges and rewards of working in cancer genomics ensure that we're never bored. We have high standards. In our domain, details really matter. We take joy in teamwork and collaboration. Our tech stack includes Django, Postgres, Django Rest Framework, D3, SCSS, AWS, VMWare, Docker, Jenkins, Saltstack, Terraform, Selenium, git, and Torque (yes, Torque). The software department has technical leadership and includes specialists in bioinformatics, algorithm development, web development, UX design, DevOps, and software verification.

Program Manager (ADX-110-20)

ArcherDX
Greater Boulder Area
2 weeks ago
As a Program Manager you will be responsible for bringing new IVD products through the product development process. You will orchestrate and lead collaborative planning to define and execute product development processes to support the Company’s commercial business goals. This role will have responsibility for managing program timelines, identifying key risks and mitigations, and facilitating execution of program goals. As the program lead, you will interact with other departments including R&D, Marketing, Regulatory Affairs, Quality, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products are successfully launched, and that timelines and performance objectives are met.

Regulatory Affairs Manager (ADX-87-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Regulatory Affairs Manager will be responsible for representing the regulatory function on teams working on the development of in vitro diagnostic medical devices for global regulatory submissions. This position will lead, mentor and develop a team within Archer’s primary class of trade.

Bioinformatician II CDx/IVD (ADX-91-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The primary role of this position is to support the CDx/IVD team by providing maintainable and well- tested tools, as well as analysis and interpretation of results of the Archer AMP assay while adhering to ArcherDX software processes. These tasks will need to be all be performed within strict timelines as required by both internal and external stakeholders. The bioinformatician will work closely with the CDx/IVD team in analyzing and interpreting the results of laboratory experiments while providing guidance on how to best design future experiments. This role will be responsible for assisting the CDX/IVD team in troubleshooting and resolving inevitable issues that arise in assay development. This individual will elicit requirements from the CDx/IVD team in order to build software tools, perform statistical analysis, produce rich visualizations, and optimize the accuracy of algorithms in the early stages of planning and development.

Senior IT Cloud Engineer (ADX-83-20)

ArcherDX
Greater Boulder Area
2 weeks ago
ArcherDX has a unique opportunity for the right candidate to play a pivotal role in creating a culture of customer service and innovation for the department. The Sr IT Cloud Engineer will utilize their cloud skills and knowledge of server operating systems, virtualization, network infrastructure, directory services, and messaging systems to execute assigned projects that enable business objectives. This person will also implement new technologies, provide excellent customer service, employ troubleshooting techniques and perform routine maintenance in response to identified needs and requests. This role will also collaborate with internal IT team members, provide technical guidance, as well as collaborate with other departments to implement or enhance IT technical solutions

Director of Scientific Writing and Communications (ADX-66-20)

ArcherDX
Greater Boulder Area
2 weeks ago
Residing in the Boulder office, the Director of Scientific Writing and Communications leads a team in generating scientific, medical, regulatory and technical documentation for the CDx/IVD, marketing, clinical operations and R&D teams at ArcherDX. This position will report to the Chief Medical Officer and oversee research, writing and editing of pre-clinical and/or clinical protocols, diagnostic analytical validations, and other studies. They will prepare ​and/or supervise the generation of reports, summary documents, package inserts and other documents that may be submitted to regulatory authorities, publication in scientific journals, presentation at international congresses and internal communication purposes.

Regulatory Affairs Specialist - Solid Tumor (ADX-53-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Regulatory Affairs Specialist, reporting to the Sr. Regulatory Affairs Manager for the Solid Tumor program, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintainenance of the documentation associated with filing for high risk medical device for the US and OUS submissions. This position will primarily support Archer’s Solid Tumor program focused on bringing a kitted IVD solution to the targeted oncology therapy market.

Technical Software Product Manager (ADX-154-20)

ArcherDX
Greater Boulder Area
2 weeks ago
The Technical Software Product Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will centrally manage one or more projects within the commercial software department and will apply project management knowledge, skills, tools, and techniques to project activities to meet requirements and achieve desired outcomes. This position coordinates departmental or cross-functional teams, focused on delivering new or upgrading existing products. Additionally, the technical software project manager monitors projects from initiation through delivery including planning, directing schedules, and monitoring of budgets and spending. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk. The ideal candidate will have the ability to collect and understand user needs and requirements as they pertain to the software.

Biostatistician (ADX-47-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Biostatistician will contribute key statistical expertise to our rapidly growing Companion Diagnostics program and will assist with study design, data analysis, code development, analysis validation, and report generation. This person will work closely with program technical leads, data scientists, and quality assurance personnel to think creatively and achieve ambitious goals to advance the treatment of cancer.

System Engineer - Software (ADX-227- 19)

ArcherDX
Greater Boulder Area
2 weeks ago
 Software Engineer IV – Systems is a software engineering generalist. You might be directly debugging critical production code one day and the next you might be designing and communicating software architecture. You will be performing a delicate balance between technical excellence, timelines, and software safety. You will be a central, critical part of bringing a novel cancer diagnostic to the market. Your work will save lives.