Director, RUO Operations

| Greater Boulder Area
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people! Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

Invitae’s Boulder Site is looking for an experienced Operations Leader who will guide the development and management of our Research Use Only (RUO) Product Manufacturing and Operational Excellence. The Oncology R&D Assay Development group is responsible for designing high-quality products utilizing our Anchored Multiplex PCR (AMP™) technology. This role will be responsible for providing analysis and recommendations for process improvements, leading process improvement initiatives, and managing those overseeing planning, scheduling, and technology transfer in support of Research Use Only (RUO) product demand fulfillment. This role will require cross-functional leadership and collaboration skills to coordinate operational activities with multiple stakeholders. This is a senior level role that would suit an experienced manufacturing or operations professional.

Responsibilities:
  • Provide technical, management, and business leadership in support of RUO operations by setting team goals, ensuring appropriate training, establishing a high level of expertise, and working collaboratively with key partners;
  • Oversee RUO production related activities, procedures, and records. Provide guidance in the diagnosis and resolution of production problems to ensure uninterrupted demand fulfillment;
  • Strategically develop and oversee an RUO operations roadmap that supports business commitments while striving for lean, standardized processes;
  • Develop and maintain Key Performance Indicators (KPls) to facilitate continuous improvement of our end-to-end processes. Sponsor and drive continuous improvement projects, both within the RUO operations team and cross-functionally as it pertains to RUO value streams;
  • Ensure team members are trained in cGMP manufacturing to meet relevant regulatory and quality standards for products;
  • Develop and/or test the feasibility of new manufacturing technologies and serve as the RUO Operations Leadership representative during technical transfer;
  • Collaborate with project management to ensure effective resource utilization, planning, and execution of projects that are in alignment with Global Oncology objectives;
  • Recruit, direct, coach and develop talent to maintain a high level of technical expertise that works collaboratively with key partners. Motivate, retain and develop key employees. Forecast hiring needs as the business grows and scales.
  • Develop an annual budget and achieve financial results;
  • Maintain a safe and clean facility;
  • Review, understand, and comply with Invitae HIPAA Security policies and procedures;
  • Safeguard the privacy and security of protected health information and European Union personal data;
  • Process and handle European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
Experience:
  • 10+ years of manufacturing or operations experience required, with at least 5 in the pharma, biotech or medical device industry.
  • Experience leading transformative change in a development or manufacturing environment.
  • Experience managing complex cross-functional initiatives while instilling teamwork within the organization and demonstrating key interpersonal skills
  • Knowledge of guidelines in a regulated environment (ISO13485, 21CFR820, cGMP) and related manufacturing and process control requirements.
  • Knowledge of Lean/6S and demonstrated use of skills leading transformational and continuous improvement projects preferred.
  • Experience with implementation and/or integration of Life Science system architectures such as ERP, MES, or LIMS.
Key attributes:
  • Must be hands-on, self-directed, organized, and conscientious;
  • Proficient in executing design transfers and process checks;
  • Demonstrated hands on change leadership skills;
  • Excellent written and verbal communication skills;
  • Excellent problem solving ability and ability to think systemically to identify solutions;
  • Proven ability to work under pressure and with short deadlines to accomplish objectives;
  • Ability to communicate effectively with technical and non-technical personnel.
Education:
  • Degree in life sciences or related field required; Graduate degree preferred.

In Colorado, our competitive compensation package includes a base salary starting from $170,000. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

    • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
    • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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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 Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae 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 Invitae. 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 Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
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