Senior Associate, Quality Control

At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.

Summary:

Intellia Therapeutics has an exciting new opportunity for a Senior Associate, Quality Control. In this role you will have the opportunity to support the activities related to internal testing and testing performed at contract organizations. In addition to coordinating testing related activities, you will support efforts to acquire, transfer, and qualify QC methodology for raw material and product release, including assay troubleshooting and optimization. You will act as the interdepartmental liaison to cross-functional groups including Analytical Development and Quality Assurance.

Responsibilities:

• Perform review of QC data in support of GMP clinical trial material in compliance with SOPs.
• Perform in-process testing according to test methods. Trend testing results.
• Coordinate internal and external testing activities including sample management and shipments.
• Track work orders, purchase orders, and invoices, to ensure continuity of testing.
• Initiate and author document change controls, deviations, and CAPAs.
• Troubleshoot and provide additional technical support for method, material, and instrument-related issues.
• Support of test methods, technical method transfers, qualifications, and reports.
• Assist in the implementation and maintenance of general lab operational systems in accordance with GxP compliance to maintain functionality.
• Serve as the cross-functional team member for assigned projects.

Qualifications:

• BS with 4-6 years' GMP lab experience.
• Experience conducting testing and reviewing QC data in support of GMP.
• Ability to effectively resolve technical issues using a variety of methods, including but not limited to: HPLC, UV, CE, Bioassay, gel electrophoresis, and compendial testing.
• Technical writing experience including creating, revising, and reviewing SOPs, protocols, reports, technical assessments, and technical memos.
• Knowledge of the use and interpretation of pharmacopeias such as USP/NF, EP, and JP.
• Knowledge and experience with electronic systems such as EDMS, LIMS, etc. preferred.
• Detail oriented with the ability to manage multiple, competing priorities.
• Demonstrated knowledge of method transfer, qualifications, and validations.
• Strong verbal and written communication skills.
• Background in analytical development with project management experience a plus.

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What Intellia Stands For:

At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.