GM, Colorado Operations (ADX-342-20) at ArcherDX

| Greater Boulder Area
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GM, Colorado Operations (ADX-342-20)
COMPANY SUMMARY:
 
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
 
 
POSITION SUMMARY:
Operations Management professional who will lead the development and management of the company’s IVD/CDx and RUO manufacturing capabilities, to include operations and engineering departments. This role will be hands-on and will provide overall manufacturing leadership for Colorado Operations to develop, execute and manage new product manufacturing via process development and validation and test method validation. This position will ensure the company provides its internal and external customers with industry leading and innovative products and services that meet or exceeds established requirements including US FDA regulations, GMP (good manufacturing practice) and ISO 13485:2016.
RESPONSIBILITIES:
  • Develop and oversee cGMP-level production related activities, procedures and records for IVD and companion diagnostic manufacturing and logistics;
  • In coordination with Strategic Operations, implement and execute manufacturing operations to meet and/or exceed the strategic goals of the company’s global regulated product manufacturing, engineering, and associated process lines;
  • Provide guidance and leadership in the diagnosis and resolution of production problems; 
  • Develop and/or test the feasibility of new manufacturing technologies and their introduction into a cGMP environment;
    Manage external subcontractors:
  • Lead by example to create an inclusive culture that values high engagement;
  • Collaborate with the Diagnostic Strategy Program Management Office to ensure effective resource utilization, planning, and execution of projects that are in alignment with company objectives;
  • Recruit, direct, coach and develop talent in the Colorado Operations organization to maintain a high level of technical expertise that works collaboratively with key partners;
  • Review personnel performance and compensation;
  • Responsible for all hiring decisions within the team, including obtaining new position approvals;
  • Develop annual budget and achieve financial results;
  • Develop, monitor and report on KPI’s related to operations;
  • Assist and provide critical feedback on production process development;
  • Partner cross-functionally on needed logistics capabilities;
  • Advise on scalability and product/services expansion;
  • Build and maintain positive and collaborative relationships cross-functionally with management, peers, subordinates, and externally with third party suppliers, contract organizations, and regulatory authorities to advance strategic priorities; 
  • Maintain safe and clean facility and site;
  • Prepare for and participate in audits;
  • Review, understand, and comply with ArcherDX HIPAA Security policies and procedures;

EXPERIENCE:
  • 10+ years experience leading transformative change in a development or manufacturing environment;
  • Demonstrated success in manufacture of IVDs would be highly desirable;
  • Experience developing a scalable efficient compliant organization;
  • History of integrating processes in medical device manufacturing and maintenance;
  • Working knowledge of cGMP/CFR/FDA regulations and ISO standards.

KEY ATTRIBUTES:
  • Must be hands-on, self-directed, organized and conscientious;
  • Demonstrated hands on change management leadership skills;
  • Excellent written and verbal communication skills;
  • Problem solving prowess in consistently evolving environment;
  • Proven ability to work under pressure and with short deadlines to accomplish objectives;
  • Ability to communicate effectively with technical and non-technical personnel.

EDUCATION: 
  • Bachelor’s degree required;
  • Graduate degree in molecular biology, engineering and/or relevant scientific discipline highly desired;
  • Knowledge of manufacturing in a regulated environment (ISO 13485, 21CFR820, cGMP) and related manufacturing and process control requirements.
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

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.

Sarah

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.

Judy

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.

Aaron

VP of Bioinformatics and Commercial Development

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

Culture
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
Diversity
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)
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
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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