Principal Scientist, Potency Assay Development

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More with Intellia:

As a Principal Scientist of Potency Assay Development, you will join ourquickly growing Analytical Development team within the Technical Operations group and embrace the opportunity to transform amazing sciences and technologies into powerful cures.Youwill focus on developing, troubleshooting, and qualification/validation of cell-based bioassays and immunoassays, as well as developing internal analytical capabilities to support in-house process development. The successful candidate will have expertise in developing functional cell-based assays to evaluate the relative potency of drug substance and drug product. Responsibilities include:

• Independently design, develop, optimize, qualify and/or validate and transfer novel cell-based bioassays and immunoassays for relative potency and neutralizing anti-drug antibody endpoints

• Draft and review SOPs, technical reports, and regulatory documents

• Supervise and mentor laboratory research associates and scientists

• Represent the Analytical Development function on matrixed CMC and other development teams

• Transfer analytical methods internally or to contract laboratories; manage internal experiments and trend internal method performance and specifications

• Lead comparability testing to support process changes and transfers.

• Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences, including regulatory agencies

• Act as a technical resource in investigations, health authority inquiries and regulatory filings

• Assess method performance and identify issues and propose and implement appropriate remediation in conjunction with QA and company policies

• Familiarity with statistical concepts and design of experiments (DoE) related to functional cell-based assay development, optimization, and validation

About you:

• Ph.D. in Biochemistry, Cell Biology, or a related field with 5 or more years of experience in an industrial setting

• Experience working in a regulated pharmaceutical industry setting

• Gene and/or cell therapy experience preferred

• Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g., ELISA, MSD, flow cytometry and cell-based - proliferation, phosphorylation, reporter and cytotoxicity assays)

• Knowledge of GMP as relevant to laboratory practices in sample handling and analysis of GLP and GMP samples

• Knowledge of industry USP/ICH guidances for the development, qualification/ validation of functional cell-based assays and potency methods

• High competence in standard software and data analysis packages (e.g., PLA software, SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools)

• Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team

Meet your future team:

The Analytical Development team is a group of energetic, brilliant, fun and motivated individuals. We work on different modalities and still work as a Team to achieve our goals. This group is responsible for developing robust and innovative analytical methods to support internal and external manufacturing processes. We support Intellia’s clinical programs and in vivo and ex vivo emerging pipelines. While much of the day-to-day operations require wet lab work, our team focuses on building everyone’s technical expertise and fostering an environment for career growth as scientists and engineers in the biopharmaceutical industry.

Covid-19 Vaccination Policy:All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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.