Associate Director, Analytical Development (Bioassay)

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/Group Leader, 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 be overseeing the design, development, execution, transfer and qualification of bioassay to quantitate and characterize a variety of molecular targets relevant to manufacturing and testing of gene therapy and cell therapy platforms.  

Main responsibilities also include:

• Leads the Bioassay analytics for all programs and defines science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during advancing clinical development stages

• Provides strong knowledge, mentorship and technical leadership of analytical development processes to train junior staff and continuation of in-house analytical capability build

• Oversees the development, qualification and validation of analytical test methods and technology transfer at outsourced Contract Research and Contract Manufacturing Organizations (CROs/CMOs), in accordance with ICH guidance documents, including management of associated deliverables and timelines

• Works closely with process development to ensure that an analytical strategy is developed for testing based on CQA identification, process control strategies as well as process development and characterization needs

• Works closely with, and supports quality control on technical investigations, OOS, OOTs and release assay troubleshooting

• Provides primary technical expertise for analytical sections for regulatory filings

• Leads the establishment of in-house systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities at its in-house facility

• Oversees the establishment of in-house infrastructure (Analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination and control of critical reagents etc).

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

About you:

Are you interested in working in the analytical development group? Are you skilled in analytical method development focused on bioassay method development? 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 within CMC/Technical Operations required

• Must have experience with AAV gene therapy. Cell therapy, LNP and mRNA experience a plus

• Must have experience with regulatory submissions

• 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 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 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.