Technical Process Scientist II at Invitae (Formerly ArcherDx)

| 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. We are passionate about what we do!


POSITION SUMMARY:

The Technical Process Scientist position is responsible for process development, process engineering, and maintenance of commercial operations.  This position will work closely with Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliance and efficient processing of the manufactured products.


RESPONSIBILITIES:

Job performance will involve a variety of activities including:

  • Maintain compliance with QA and Current Good Manufacturing Processes (cGMP) requirements.
  • Analyze and develop processes to support manufacture and testing of product lines in cGMP or RUO settings.
  • Investigate and troubleshoot equipment, product testing and process abnormalities to improve measurable process outputs.
  • Identify, drive, and document cross-functional communication for process improvement projects
  • Create and engineer commercial operations processes capable of meeting or exceeding determined key performance indicators.
  • Author, revise and review standard operating procedures, test methods, work instructions and travelers (batch records)
  • Accurately document all necessary relevant information in a clear and concise manner per cGxP
  • Collaborate with various functional groups such as QC, Manufacturing, Logistics and Engineering to assist in technical transfer or improvement of the processes and test methods
  • Understand the scientific principles required for manufacturing products, including the interaction of the chemistry, equipment, aseptic processes, and ISO systems
  • Ensure that an accurate instruction set and process flow document, describe the process as performed and adhere to the control strategy for the discrete manufacturing steps.
  • Prepare, review, approve, or provide technical support for preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, validations, processing records, procedures, process flow documents, control plans, annual product reviews, etc.
  • Support and/or lead the development and implementation of process improvements to improve process control, and/or productivity.
  • Participate in development and implementation of process improvements including capital expansions and technical projects.
  • Work within or lead cross-functional teams to implement functional objectives and deliver on business plan and quality objectives.
  • Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
  • Safeguarding the privacy and security of protected health information and European Union personal data.
  • Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.

KEY ATTRIBUTES:

  • Drive and determination
  • Ability to work in a fast paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong communication and presentation skills
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction 
    • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
       

QUALIFICATIONS:

  • MS degree with 3+ years of experience OR BS degree with 8+ years’ experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience.
  • 2 years of experience is with laboratory and industry settings operating in a regulated environment.
  • Experience in regulated environment such as ISO13485, ISO90001, cGMP
  • Process development experience to help improve and scale-up current manufacturing processes
  • Must have demonstrated expertise in authoring SOPs or similar process directed documentation
  • Familiarity with statistical data analysis, qPCR/PCR and general molecular biology techniques, root cause analysis, and equipment. 
  • Next Generation Sequencing operating, and analysis experience preferred.
  • Microsoft Office (Word, Excel and Outlook) and flow-charting software (preferred)
  • Lean Six Sigma or other continuous improvement technique experience/certification a plus

In Colorado, our competitive compensation package includes a base salary starting from $75,280 per year.  In determining the final salary offered, we will evaluate a specific candidate's 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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Technology we use

  • Engineering
    • C++Languages
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    • PythonLanguages
    • RLanguages
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    • SqlLanguages
    • D3JSLibraries
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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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