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

| Greater Boulder Area
Functional Project Manager QA/Regulatory (ADX-202-19)
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THE COMPANY: ArcherDX, Inc. -


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 enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

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.
Job performance will involve a variety of activities including:
  • Assist QA & Regulatory owners/authors with creating plans for the acquisition, review, and finalization of key documents and deliverables for submissions to global regulatory authorities (e.g. notified bodies, FDA, PMDA, NMPA).
  • Standardize communications within the Regulatory and Quality department as well as provide regular status and progress updates to Archer’s senior management and core launch teams.
  • Strategize with Quality and Regulatory management for the balancing of competing priorities, challenging timelines, and resource deployment.
  • Coordinate between the USA and rest-of-world Quality and Regulatory activities to provide comprehensive departmental visibility to all new product submissions and change applications worldwide.
  • Drive consistent communication in a fast-growing organization among cross-functional teammates as well as external partners (e.g. pharmaceutical co-development partners, contract vendors).
  • Collaborate closely with the Project Management Office to ensure project managers possess accurate information on regulatory deliverables.
  • Provide input on regulatory dashboards for review by senior management.
  • Document key project decisions and facilitate information management processes
  • Prioritize team and physical resource allocations.
  • Implement processes to manage and control all types of project change
  • Lead project team meetings, develop agendas, follow-up on action items
  • Address the needs, concerns, and expectations of all stakeholders through active and collaborative communication
  • Effective verbal and written communication with internal and external stakeholders including clients and regulators.
  • Willingness to travel up to 10% of the time.
  •  Support project teams through the initiation, planning, execution, monitoring/control, and closing of their projects by providing sound project management expertise and coaching.
  • Facilitate issue and risk management in collaboration with the project/program teams. 
  • Support the implementation of standard project and business management processes and tools. These processes and tools may include the development, monitor, and control of integrated timelines, budgets, risk management plans, communication plans, and business process maps.
  • Generate or integrate project-specific metrics/reports and analyzing options and opportunities to optimize the project team’s productivity.
  • Collect data for and prepare accurate management of governance committee updates on project status using appropriate templates and tools.
  • Establish, maintain and use information repositories and collaboration sites.
  • Identify and mitigate project risks.
  • Must have demonstrated knowledge of project management skills, tools, and processes in areas such as timeline, cost, and risk management.
  • Proficiency in standard project management software and enterprise resourcing planning.
  • Effectively communicate project status to external pharma partners throughout the development process
  •  Bring forth solutions to meet timelines when at risk. Including manufacturing, software, regulatory, assay development, validation, etc… 
  • Must have experience operating at the individual project level for organizational project management.
  • Minimum of 5 years' experience in the diagnostic or pharmaceutical industry.
  • Proven ability to coordinate multifaceted projects, including multitasking, deliverables management, and timeline management.
  • Demonstrate the ability to work within a commercial environment and influence with and without authority in a cross-functional role.
  • Experience in diagnostic development or similar development paradigm
  • Understanding of 510k and PMA diagnostic approval process from concept to submission.
  • Understanding of clinical trial logistics and brining drug and diagnostic from concept to approval.
  • High energy, self-motivated, approachable and articulate team player.
  • Demonstrates strong leadership capabilities with the ability to lead a cross-functional team (assay development, laboratory, clinical, software, etc.) through a complex development program.
  • Significant experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company.
  • Demonstrated ability to design and develop products and to interpret and evaluate clinical data.
  • The ability to forge strong internal and external partnerships coupled with excellent presentation, communication and interpersonal skills.
  • Excellent oral and written communication skills.
  • Strong interpersonal, team working, and leadership skills.
  • Strong attention to detail demonstrating accuracy in tracking and reporting data.
  • Good problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent a recurrence.
  • Independent self-management and organizational skills; able to manage workload, set personal and project priorities and adjust as needed.
  • Flexibility to adjust quickly and effectively to frequent change and altered priorities.
  • Excellent work planning and execution/delivery skills – includes problem-solving, prioritization, and task-level influence skills.
  • Ability to influence without power.
  • Strong ability to communicate both at a detailed (e.g. task status, task management, task execution) level and management through the executive level (e.g., high-level summary verbal and written to sponsors of the planning and execution status).
  • BS/MS/Ph.D. preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences or equivalent experience.
  • Project management certification (PMP®, PRINCE2®) or equivalent required.
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Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.


Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.


Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.


VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!


Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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