Jobs at ArcherDX
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Technical Supervisor (ADX-111-19)

ArcherDX
Greater Denver Area
1 day ago
+32
The Technical Supervisor may function as the Technical Supervisor and General Supervisor. They must provide technical supervision monitor test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained. The Technical Supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory to provide supervision or consultation (as needed).

Director, Payer Accounts (ADX-185-19)

ArcherDX
Greater Boulder Area
2 days ago
+32
The Director, Payer Accounts, will support the company’s business imperatives by leading the immediate reimbursement strategy and ensuring success of short term business objectives by focusing on two phases of development: Phase 1 includes pre launch activities such as: building relationships with internal and external customers and compilation of a payer dossier. These relationships and tactical activities will lead a fast start for Archer’s IVD CDx. Phase 2 includes supporting the ongoing operational component by ensuring successful execution of public and private payer strategies in the hospital, IDN, and laboratory environments. This position will lead projects from beginning to completion based on the needs of the company. This position requires a strategic individual with previous hands on experience and expertise with both pre-launch and post-launch activities. 

Software Developer/Data Engineer (ADX-98-19)

ArcherDX
Greater Boulder Area
2 days ago
+32
This is an opportunity to build infrastructure to power innovative biotechnology. Residing in our Boulder, CO office will help plan, develop, and build data infrastructure critical to our In Vitro Diagnostics program. Will be responsible for the accuracy and usability of data central to regulatory approval of ArcherDX’s diagnostics. 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 genetic diseases.

Quality Specialist (RUO) I/II (ADX-190-19)

ArcherDX
Greater Boulder Area
2 days ago
+32
Assist with manufacturing/R&D documentation and support. Assist with process customer feedback. Assist with supplier issues. Manage equipment including scheduling of maintenance and calibration. Assist with the management of Complaints, Nonconformance reports, Corrective and Preventative Actions reports. Manage the document archiving and retrieving process. Maintain compliance with all company business policies and procedures. Perform other duties as assigned by supervisor.

Lab Technician (ADX-110-19)

ArcherDX
Greater Denver Area
5 days ago
+32
This position reports to the Clinical Laboratory Manager and will perform clinical genetic testing of client samples. This position is instrumental in ensuring rapid turn-around of high quality genetic testing while meeting CLIA (and other regulatory) standards.

Senior Regional Marketing Manager-East (ADX-128-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Senior Regional Marketing Manager (RMM) will be responsible for helping to position Archer externally with Key Opinion Leader’s and Key Customers. The position will work in close partnership with cross- functional partners in order to support the execution of a robust key customer strategy. This will be supporting both current and future customers as we bring exciting new products to the market over the next 12-18 months. The ideal candidates should have a solid Marketing background and work experience managing a variety of new product introductions, campaigns, and have experience in both non-personal and personal marketing techniques. It is expected that this individual will play a significant role shaping the company’s strategic planning and customer engagement capabilities for planned commercial product launches.

Genetic Counselor (ADX-158-19)

ArcherDX
Greater Denver Area
5 days ago
+32
Provide technical assistance and guidance on test availability, composition, selection, and interpretation of NGS testing to include WGS and WES. Assist with the resolution of next-generation sequencing testing issues, such as inadequate specimens, questions regarding variants, quality control. Maintain and update patient and provider materials. Review next-generation sequencing test orders for urgency and accuracy. Obtain relevant patient clinical history for case review and interpretation. Compose and review reports with laboratory medical directors. Participate in scientific and quality-assurance studies and research related to the laboratory's services. Participate in development and implementation of new or improved clinical test services based on next-generation sequencing. Follow the established policies and procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results.

Manufacturing Associate I (ADX-171-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
Associate level position for manufacturing medical devices in accordance with controlled procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) regulations and current GMP (cGMP) guidelines. Manufactures solutions, labels and fills containers, labels and assembles kits. Compiles auditable electronic or paper records of manufacturing, maintains equipment logs and monitors supplies.

Senior Software Engineer (ADX-118-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
We take code-review and testing as seriously as code-writing. Patients can’t afford for us not to. The challenges and rewards of working in cancer genomics ensure that we’re never bored. Our tech stack includes Django, Postgres, Django Rest Framework, D3, AWS, VMWare, Docker, Jenkins, Saltstack, Selenium, git, and Torque (yes, Torque).  We’re about a year into the process of adopting DevOps practices, with an eye towards increasing information flow and feedback throughout our SDLC. The software department has technical leadership and includes specialists in bioinformatics, algorithm development, web development, UX design, DevOps, and software verification.

Research Associate - Custom Assay Development (ADX-105-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Research Associate – Custom assay development position is responsible for assisting in the design, development, and evaluation of Archer custom products utilizing Archer’s AMP technology. As familiarity with AMP-based NGS increases, novel approaches to experimental design and development of new NGS products will be expected. This position is a key part of the greater RUO Assay Development team, requiring strong communication skills.

Senior Regional Marketing Manager: West

ArcherDX
Greater Boulder Area
5 days ago
+32
The Senior Regional Marketing Manager (RMM) will be responsible for helping to position Archer externally with Key Opinion Leader’s and Key Customers. The position will work in close partnership with cross-functional partners in order to support the execution of a robust key customer strategy. This will be supporting both current and future customers as we bring exciting new products to the market over the next 12-18 months. The ideal candidates should have a solid Marketing background and work experience managing a variety of new product introductions, campaigns, and have experience in both non-personal and personal marketing techniques. It is expected that this individual will play a significant role shaping the company’s strategic planning and customer engagement capabilities for planned commercial product launches. The RMM articulates the customer-facing messaging and outlines all marketing efforts to achieve this goal through multiple channels, including web content, webinars, emails & social, advertising, public relations and tradeshows. The RMM also aligns field teams with current messaging and expertise through team training and tight communication.

Sr. Regulatory Affairs Specialist (ADX134-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Sr. Regulatory Affairs Specialist, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.

Bioinformatics Research Associate II (ADX-145-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The primary role of this position is to engineer maintainable and well-tested tools for genomic sequence data analysis while adhering to ArcherDX software engineering methodologies. The bioinformatics associate will create novel tools, customize existing ArcherDX and third party tools in order to improve and accommodate new and existing applications of ArcherDX products. The bioinformatics associate will work closely with molecular biologists to analyze and interpret the results of laboratory experiments and will be able to provide guidance on how to best design their experiments. This individual will elicit requirements from the Molecular Biology team in order to build tools that will facilitate assay optimization and new product development. Assay optimization and new product development will involve determining the best assay parameters by applying and interpreting statistical analysis of the data and by creating rich visualizations of the data. It will also involve novel algorithm creation via rapid prototyping followed by rigorous testing to show a proof of new concepts.

Operational Excellence Lead (ADX-139-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Operational Excellence Lead is responsible for monitoring manufacturing operations, providing analysis and recommendations for process improvements, leading process improvement initiatives, and overseeing planning, scheduling, and manufacturing preparation activities in support of Research Use Only (RUO) product demand fulfillment. The Operational Excellence Lead will create level-loaded schedules for manufacturing while ensuring that production supplies are available in sufficient quantity to consistently execute the production schedule. This role will require cross-functional leadership skills in order to coordinate and prioritize manufacturing activities with multiple stakeholders. 

Technical Support Specialist - Bioinformatics (ADX-150-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Technical Support Scientist - Bioinformatics provides technical support and training on ArcherDX products from Archer headquarters in Boulder, CO. This individual will also conduct sales and support trainings for Archer employees. In addition, this individual will support pre-launched products (software related). This individual will collect feedback and voice of the customer and share with internal teams to improve products. This individual will assist in coordinating activities for special programs as needed.

Biostatistician (ADX-47-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
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.

Site Reliability Engineer (ADX-100-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
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.

IT Applications Systems Engineer (ADX-152-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
Act as a Business Analyst and work across the organization with many different departments. In this role, the candidate will gather requirements, guide process mapping with various departments critical processes and help guide software validation initiatives. Act as a System Analyst. This role will work across IT and various business units to bring a common mindset for software implementation and identifying future goals. The selected candidate will work with system stakeholders, including internal users, customers, and investigators to ensure that our platforms provide an outstanding user experience. Act as a Systems Engineer. This candidate will also have the opportunity to act as the systems engineer role in which they will be tasked with building/implementing/configuring the technical design of assigned applications based upon the designated business requirements.

Desktop Support Specialist (ADX-120-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
The Desktop Support Specialist provides hands-on technical and administrative desktop support for our global team in the US and Europe. As a Desktop Support Specialist at ArcherDX you’ll use your expertise in operating systems, business application software and hardware to provide excellent support to our internal team. This position supports desktop computers and peripherals at ArcherDX’s headquarters and remote locations. Support includes monitoring jobs and responding to errors with the applications, the installation, configuration, testing and ongoing usability of desktops, peripheral equipment, software and other related equipment.

Software Intern (ADX-05-19, ADX-06-19)

ArcherDX
Greater Boulder Area
5 days ago
+32
Push the frontier of precision medicine as a Software Intern. The internship will be a great opportunity to be introduced to real world experience in clinical diagnostics in the oncology space. The experience will immerse you in Archer's cutting edge targeted sequencing assay and to the array of its real world applications; including the detection of: CNVs, Lymphoma Subtypes, Somatic Mutations in FFPE and ctDNA, Gene Fusions, Structural Variations and VDJ Clonotypes. And these are just the applications that have been commercialized, the R&D team continually works towards new applications in both the RUO and CDx space. Opportunities are also available in supporting our vast array of tools in the cloud.

Medical/Scientific Writer (ADX-22-19)

ArcherDX
Greater Boulder Area
5 days ago
The Medical/Scientific Writer generates documentation review for the CDx/IVD Assay Development team at ArcherDX. The Medical/Scientific Writer researches, writes and edits pre-clinical and/or clinical reports including diagnostic analytical validations, summarizing data from said studies. Prepares ​analytical validation and clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and the World Health Organization for publication and/or presentation. Assists in the development of formats and guidelines for clinical documentation. May prepare scientific manuscripts, abstracts and posters. May also support clinical research associates and medical doctors in clinical protocol development. Keeps abreast of professional information and technology through conferences.

Project Manager-IVD (ADX-116-19)

ArcherDX
Greater Boulder Area
5 days 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.

Clinical Research Associate (ADX-115-18)

ArcherDX
Greater Boulder Area
5 days ago
Coordinate all aspects of study site monitoring, including study file maintenance, according to established plans and procedures. Maintain regular communication with CRO staff, following up on protocol deviations to resolution. Prepare accurate and timely trip reports, and deviation summary reports for the project core team. Act as a contact for shipping and tracking of clinical trial supplies for the CRO sites. Assist sites with site-level IRB submissions, queries and documentation . Travel is required domestically and internationally, up to 35%. Other duties as assigned.

Software Engineer I/II - Verification Tools (ADX-127-19)

ArcherDX
Greater Boulder Area
5 days ago
The primary role of this position is to contribute high quality and well-tested code to an existing set of verification tools designed for the testing of bioinformatics data processing workflows. Implemented code will either be refactors or novel products created to specifications. The work product will be used to support verification of both the Research Use and Clinical products.

Clinical Data Manager (ADX-131-19)

ArcherDX
Greater Boulder Area
5 days ago
The Clinical Data Manager will join our rapidly growing Companion Diagnostics Program and contribute key support and expertise to our analytical validation and clinical studies. With a focus on detail, the clinical data manager will play a critical role in designing and executing approaches for managing clinical data. This person will interface with clinical operations, statistics, and data science personnel as well as external partners to ensure accurate, documented, and regulatory-compliant data from studies pivotal to ArcherDX’s platform.

Recruiter (ADX-170-19)

ArcherDX
Greater Boulder Area
5 days ago
The Recruiter will report to the Recruiting Specialist and will be responsible for sourcing and recruiting for the organization. The successful candidate thrives in a fast-paced environment and has the ability to foresee needs and drives the recruitment process with a focus on positive candidate experience.

Recruiting Coordinator (ADX-222-19)

ArcherDX
Greater Boulder Area
1 week ago
The Recruiting Coordinator will report to the Corporate Recruiter and will be responsible for coordinating with candidates. The successful candidate thrives in a fast-paced environment and has the ability to foresee needs and drives the recruitment process with a focus on positive candidate experience.

Senior Manager/ Associate Director of Quality Analytical Services (ADX-215-19)

ArcherDX
Greater Boulder Area
1 week ago
The Senior Manager/ Associate Director of Quality Analytical Services will establish, oversee and manage quality analytical services under good manufacturing practice operations to include quality control testing, test method validation, stability program, and laboratory management. S/he will provide leadership to establish and maintain quality levels that meet and exceed customer expectations in the laboratory in compliance with US FDA Regulations and ISO 13485:2016 standards. Function includes management and oversight over the Quality Control departments, test method validation program, and stability program; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensuring department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.

Supply Chain Coordinator (ADX-218-19)

ArcherDX
Greater Boulder Area
1 week ago
We are looking for an experienced and motivated supply chain professional that has a background in supply chain and life sciences to join our team. This position will be responsible for the overall management of our consumable inventory, including planning, executing, monitoring and troubleshooting. This role will be responsible for data verification and entry including MO/WO closure and updating ERP information. This position requires high attention to detail and the ability to interface with suppliers.

Quality Assurance Specialist (QMS Compliance)

ArcherDX
Greater Boulder Area
1 week ago
The Quality Assurance Specialist will provide support in the quality system area of Compliance. Additionally, the Quality Assurance Specialist may provide support to one or more quality system area(s) of Training, Document Control, Risk, CAPA, Root Cause Investigations, Complaints or Design Quality Assurance on an as need basis.

Quality Engineer (RUO) (ADX-213-9)

ArcherDX
Greater Boulder Area
1 week ago
The Quality Engineer will work in the Research Use Only (RUO) environment and will develop, implement and maintain an appropriate Quality Management System (QMS) in the research and development space. S/He will also assist in transfer activities of processes to the Good Manufacturing Practice (GMP) space.

Buyer I/II (ADX-219-19)

ArcherDX
Greater Boulder Area
1 week ago
The Buyer I will be responsible for the purchase goods, materials and services to ensure that the company operational needs are met, considering price, quality and delivery and to ensure continuity of supply.

Receiving Clerk (ADX-181-19)

ArcherDX
Greater Boulder Area
1 week ago
Conducts daily receiving activities for consumables, stocked, time and temperature-sensitive materials in a ISO/cGMP facility. Accurate physical and ERP system receiving of materials in order to maintain integrity of inventory control. Ensures delivery of materials to the proper department and temperature storage location.

Bioinformatics Associate (Clinical Services) (ADX-66-19)

ArcherDX
Greater Denver Area
1 week ago
The primary role of this position is to engineer maintainable and well-tested tools for genomic sequence data analysis while adhering to ArcherDX software engineering methodologies. The bioinformatics associate will create novel tools, customize existing ArcherDX and third party tools in order to improve and accommodate new and existing applications of ArcherDX products. The bioinformatics associate will work closely with molecular biologists to analyze and interpret the results of laboratory experiments and will be able to provide guidance on how to best design their experiments. This individual will elicit requirements from the Molecular Biology team in order to build tools that will facilitate assay optimization and new product development. Assay optimization and new product development will involve determining the best assay parameters by applying and interpreting statistical analysis of the data and by creating rich visualizations of the data. It will also involve novel algorithm creation via rapid prototyping followed by rigorous testing to show a proof of new concepts.

Software Engineer in Test I/II/III (ADX-216-19)

ArcherDX
Greater Boulder Area
1 week 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. As required, you will build test harnesses and other testing tools to accelerate testing.

Statistical Analyst (ADX-217-19)

ArcherDX
Greater Boulder Area
1 week ago
As a statistical analyst in the biostatistics group at ArcherDx, you will engage in analytic modeling, scripting, and/or programming, develop methods for data in various states of organization, cleanliness and structure. You will perform predictive and prescriptive data analyses to build infrastructure and accelerate product innovation, product design, and product development. You will work with cross-functional teams to gather, wrangle, cleanse, structure, and analyze data.

Inventory Management Specialist II (ADX-183-19)

ArcherDX
Greater Boulder Area
1 week ago
Maintain the cleanliness of material storage areas and ensure accuracy of ArcherDX’s inventory. Perform physical and ERP movement of materials to support customer requirements. Conduct on-site delivery of materials to the proper department and temperature storage location.

Design Quality Engineer, Assay (ADX-179-19)

ArcherDX
Greater Boulder Area
1 week ago
The Design Quality Engineer, Assay will serve as a subject matter expert on Archer’s design control project core teams. This position is expected to develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration. 

International Regulatory Affairs Specialist (ADX-133-19)

ArcherDX
Greater Boulder Area
1 week ago
Create and execute international product registration submissions to global health authorities. Represent international regulatory requirements in quality system strategy activities and project core teams. Support international distributors and authorized representatives to establish and maintain market access. Understanding of harmonized medical device standards and country specific requirements. Requires excellent technical writing skills and working knowledge of applicable scientific concepts. 

Process Automation Engineer (ADX-178-19)

ArcherDX
Greater Boulder Area
1 week ago
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. 

Product Marketing Manager (ADX-208-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Product Marketing Manager works closely with both the marketing and sales teams to drive the adoption of ArcherDX products by ensuring that the value propositions are clearly communicated to the right audience. The position conducts competitor analyses, market research and collaborates with the field sales team to define brand-marketing positions within the context of the overall product strategy. This role articulates the customer-facing messaging and outlines all marketing efforts to achieve this goal through multiple channels, including personal/non-personal, digital, advertising, public relations and tradeshows, key customer meetings, etc. The position also aligns field teams with current messaging and expertise through team training and communication.

Operations Project Manager (ADX-214-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Operations Project Manager – IVD Projects, reporting to the Director of Manufacturing, will provide leadership and expertise in planning, project management and process improvement to enable the operations department to meet its business objectives. This position will centrally manage and plan for IVD projects as they pertain to manufacturing and apply project management knowledge, skills, tools, and techniques to meet requirements and achieve desired outcomes. The position will work with departments outside of manufacturing to ensure that materials and needs are met for IVD projects. Planning, execution, monitoring & improvement within the manufacturing, facilities and operations departments will be required as well as coordination on those efforts with other Archer departments, especially the IVD development teams.

Associate Clinical Laboratory Director (ADX-120-18)

ArcherDX
Greater Denver Area
2 weeks ago
ArcherDx Clinical Services, Inc is seeking a full-time Clinical Molecular Geneticist to join our team as our Associate Clinical Laboratory Director. The ideal candidate will have a strong technical background in NGS as well as certification and accreditation experience with CLIA/CAP. We are looking for someone who wants to be part of the next-generation delivery of personalized health. Candidates with experience in oncology genomics Experienced, board-certified geneticists are encouraged to apply.

Director - IVD/CDx Assay Development (ADX-211-19)

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

IVD Research Associate/Senior Research Associate (ADX-74-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Research Associate will plan, contribute to experimental design, execute experiments, and analyze data for these responsibilities with only high-level guidance and deliver reports according to deadlines. The Research Associate is expected to lead the production of high-level data summaries upon project completion that effectively and concisely communicate relevant findings for the study. The Research Associate will also assist with other IVD Assay Development activities as needed included but not limited to formulation optimization, QC, QA report filing, and equipment maintenance. The position is expected to keep detailed experimental records and communicate data to supervisors and peers in a thorough and honest manner.

Senior Scientist - IVD/CDx Assay Development (ADX-72-19)

ArcherDX
Greater Boulder Area
2 weeks ago
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.

Principal Scientist/ IVD Manager - IVD/CDx Assay Development (ADX-156-19)

ArcherDX
Greater Boulder Area
2 weeks ago
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.

Supplier Quality Assurance Manager (ADX-206-19)

ArcherDX
Greater Boulder Area
2 weeks ago
Manage and administer the SQMP. Assess and implement improvements to the SQMP as needed. Develop and manage the supplier audit schedule. Implement quality agreements with suppliers. Perform and/or arrange for performance of supplier audits. Manage supplier related Nonconformance reports, Corrective and Preventive Actions reports. Manage supplier change management. Monitor and report supplier performance using meaningful metrics. Act as a subject matter expert for the SQMP in customer and regulatory audits.

Clinical Research Manager (ADX-209-19)

ArcherDX
Greater Boulder Area
2 weeks ago
ArcherDX is hiring a Clinical Research Manager to help lead clinical trials in the Companion Diagnostic Program. In this role, you will be responsible for the day-to-day management of clinical trials and will manage the study management 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. This position is a key member of the Clinical Development team and responsible for ensuring the achievement of own or others’ project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all the duties or functions of subordinates.

MES Engineer (ADX-175-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Manufacturing Systems Engineer is responsible for implementing, maintaining, and enhancing digital 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 and implement manufacturing systems solutions. 

Human Resources Manager (ADX-169-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Human Resources Manager will report to the VP of Human Resources and will be responsible for evaluating employee programs, recommending improvements to employee relations policies and making sure that all employee-related policies in each department align with our corporate goals and values. The ideal candidate will have an entrepreneurial spirit and a customer centric mindset. We are looking for someone with a general knowledge of Human Resources , experience with employee relations and a passion for employee development and engagement.

Functional PM QA/Regulatory (ADX-202-19)

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.

Technical Writer (ADX-204-19)

ArcherDX
Greater Boulder Area
2 weeks ago
The Technical writer position is responsible for documentation of processes and specifications utilized in the PSP manufacturing department. They will work closely with Manufacturing, Quality Control/Assurance, Research & Development, and Logistics teams to translate laboratory processes into approved internal documents. They will author and revise internal documents and identify areas of improvement. 

Quality Assurance Specialist II/III (Production/Manufacturing QA) (ADX-191-19)

ArcherDX
Greater Boulder Area
3 weeks ago
Assigned as direct QA support to production/manufacturing of ArcherDX assay components and processes. Support of other Production-related activities including raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, shipping verification, etc. Timely review of batch records (Travelers) and product release. Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment. Assist in managing equipment, including installation and monitoring of maintenance and calibration. Assist Quality Engineers with internal and external audits, and follow up on required actions. Assist with the management of Nonconformance reports, and Corrective and Preventive Actions reports, and complaints. Maintain compliance with all company policies, quality systems, and procedures. Perform other duties as assigned by supervisor.

Functional PM IVD (ADX-203-19)

ArcherDX
Greater Boulder Area
3 weeks ago
The Project Mnaager 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.

Quality Assurance Specialist II/III (New Product Development/Transfer) (ADX-195-19)

ArcherDX
Greater Boulder Area
3 weeks ago
The Quality Assurance Specialist, reporting to a Quality Engineer, will support New Product Development and production transfer activities in an ISO 13485 and GMP-regulated environment. The individual must have a strong knowledge and application of the CFR and cGMP regulations to support the product launch.

Sr Project Manager-IVD (ADX-200-19)

ArcherDX
Greater Boulder Area
3 weeks ago
The Sr 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.

Regulatory Affairs Specialist (ADX-174-19)

ArcherDX
Greater Boulder Area
3 weeks ago
The Regulatory Affairs Specialist, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.

Sr. Regulatory Affairs Manager (ADX-172-19)

ArcherDX
Greater Boulder Area
3 weeks ago
The Sr. 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.

Regulatory Affairs Associate

ArcherDX
Greater Boulder Area
3 weeks ago
The Regulatory Affairs Associate, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.