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 want all of our 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 an Associate Director/Director Analytical CMC Lead, you will join the Analytical Development team within the Technical Operations group and embrace the opportunity to transform amazing sciences and technologies into powerful cures. As a senior member of the analytical development department, you will serve as the analytical lead on cross-functional late-stage product teams. As Analytical Team Technical Lead, you will represent Analytical Development and be responsible for communicating and executing the Analytical strategy for Intellia’s in vivo/ex vivo clinical asset(s). Additional responsibilities include:
Represent AD within the CMC teams and across Intellia as required
Establish and communicate analytical program goals and ensure operational plans are in place to execute the analytical strategy for the program(s)
Lead the analytical comparability studies including authoring of protocols and reports
Lead the risk assessment and documentation of CQAs for the late-stage product
Lead AD team meetings to communicate and prioritize activities for the late-stage programs
Author and review Module 3 contents for the late-stage program(s)
Are you interested in working in the analytical development group? Are you a strong leader with a deep analytical development skillset? If you say yes, we encourage you to apply! Other qualifications and desired skills include:
Ph.D. in chemistry, biology, biochemistry or related field and 6+ years of experience or Masters’ degree and 10+ years’ experience in analytical development within a biotech/pharmaceutical analytical development or within CMC/Technical Operations required
Must have experience with AAV gene therapy, cell therapy, LNP and/or RNA
Must have experience with regulatory submissions
Must be a good technical writer with experience writing technical documents including comparability protocols/reports
Must have an in-depth understanding of analytical comparability studies
Knowledge of industry USP/ICH guidances for the development, qualification/ validation of analytical methods
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. We are a small but growing family. This group is responsible for developing robust and innovative analytical methods to support internal and external manufacturing processes. We support Intellia’s clinical programs as well as in vivo and ex vivo emerging pipelines. While much of the day-to-day operations require wet-lab work, our team focus is on not only building everyone’s technical expertise but also fostering an environment for career growth as scientists and engineers in the biopharmaceutical industry.
You will report to the Senior Director, Analytical Development. She loves to see people grow and develop and looks forward to learning from your experiences and building the team together with you.
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.