How you will Achieve More with Intellia:

As an Associate Director/Director Product Quality 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 Quality Product Lead on cross-functional late-stage product teams

This role will support Intellia’s in-vivo and ex-vivo programs. The individual will be key in supporting product quality initiatives in Analytical Development. You will provide technical expertise and project support to the Analytical Development team for developing and monitoring control strategy for product quality to meet CMC deliverables. The responsibility includes:

• Provide key support for science and risk-based evaluation of complex process and product quality data including justification of specification, comparability assessment and method performance evaluation.

• Provide internal analytical development quality support including actions required for data monitoring (release, stability and in-process testing), product quality impact assessment, and support for method qualification/validation and transfers as needed.

• Communicate complex information to AD leadership, peers and cross-functional team in CMC.

About you:

Are you interested in working in the analytical development group? Are you a strong leader with a deep analytical development skill set and a proven? 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 a Masters degree and 10 years’ experience in analytical development within a biotech/pharmaceutical analytical development or within CMC/Technical Operations required

• Must be familiar with statistical analysis or interpretation for comparability criteria and specification setting

• Demonstrate proficiency in cGMP and regulatory environment

• Former quality control or quality assurance experience is a plus

• 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 guidance 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. 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 focuses on building everyone’s technical expertise and fostering an environment for career growth as scientists and engineers in the biopharmaceutical industry.

You will report to the Vice President, of Analytical Development. She loves seeing people grow and develop and looks forward to learning from your experiences and building the team with you.

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.