Cell Therapy MSAT Lead, Process 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 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:
Intellia is seeking a highly motivated, self-starter who wants to be part of a results-oriented team in a new function as MSAT Lead in genome-edited Cell Therapy technologies. If this is you, join us to play a critical role in CMC life cycle management, establishing manufacturing standards and process controls, and technical oversight of external manufacturing partners and product/process capability to enable a robust and scalable global cell therapy manufacturing network to support Intellia’s growing pipeline of autologous and allogeneic programs. Partner effectively with counterparts at CDMOs and key suppliers to meet goals of reliable, robust cell therapy manufacturability and high product quality including:
Process technology transfer and scale-up including process facility-fit assessments;
Author/review, at scale bill of materials (BOM), process flow diagrams (PFD), generate process models;
Define process operating ranges, acceptable ranges and design space requirements for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA);
Perform process monitoring and SME support (manufacturing data summary and analysis, data presentation), and serve a PiP during key unit operations and critical production campaigns;
Author campaign summary reports and performs activities for lot release (assess deviations and process changes);
Support Root Cause investigations and Deviations to ensure timely release of manufactured product using a systematic approach with problem-solving tools such as Fishbone, 5 whys, etc;
Assess change controls for impact to process, equipment or procedures that can affect process performance and product quality
Work cross-functionally and collaboratively to meet company milestones timely and drive MSAT deliverables in cell therapy
Your solid understanding of bioprocess engineering principles, strong analytical and critical thinking skills and highly collaborative nature allows you to dissect challenging problems, impact optimization of manufacturing processes and interact effectively with team members across multiple functional areas:
BS/MS in chemical engineering, biological engineering, biology or related discipline and 8+ years of relevant cell therapy industry experience in a directly related role
Significant biotech industry experience supporting allogeneic and /or autologous cell therapy process development/process scale-up / tech-transfer/manufacturing, preferably with either CAR-T cell or stem cell process development or manufacturing experience.
Must have demonstrable hands-on skills in the development, optimization and manufacturing of cell therapy products preferably T-cells, to include scale-up, process development, and risk analysis; experience with process characterization and late-stage development is highly desirable
Solid understanding of in vitro cellular assays such as cell counts and flow cytometry for troubleshooting and CDMO support.
Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team)
Meet your future team:
You will be an anchor member of a growing MSAT function at Intellia and will work to resolve manufacturing challenges, assess new manufacturing solutions and drive continuous cell therapy manufacturing process improvements. You will be a core member of the CT team responsible for the Intellia ex vivo pipeline products. This role interfaces closely with our scientists and engineers in Process Development, our External Manufacturing Supply Chain and Quality teams within our Technical Operations department. Tech Ops team is responsible to ensure the creation of our potentially curative drugs for use in clinical trials, and for ultimately scaling and ensuring production for use in commercial launch.
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.