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:
Are you a deeply motivated, proven process science leader with strong technical skills in Cell & Gene Technologies? Are you inspired to join an established biotech company to forge a new MSAT function providing critical leadership in all stages of CMC lifecycle in a rapidly growing pipeline of innovative gene-editing therapeutics? In this essential new function as Director of Cell Therapy and Viral Vector MSAT, you will be responsible for operationally-focused technical leadership in cell therapy and viral vector technologies and be joining a talented and inspired team in Tech Ops team to advance Intellia’s mission as well as your own professional development. Key responsibilities will include:
Partner effectively with counterparts at CDMOs and key suppliers to meet goals of reliable, robust manufacturability and high product quality including tech transfer and scale-up including process facility-fit assessments including Failure Modes and Effects Analysis (FMEA)- and Risk Assessments
Collaborate with Quality colleagues to ensure high-quality product and timely resolution of Quality items: deviation management, change management and CAPAs;
Collaborate closely with Process Development to author and/or review Process Flow Diagrams, Bill of Materials, Production Batch records;
Prioritize and execute MSAT tasks to meet program commitments on time and in-full
As product pipeline advances clinically, support process characterization, process comparability, process control, PPQ and PV activities.
Serve as technical process science SME in regulatory submissions and interactions by providing guidance and content as needed
You are at ease in a matrix-based workplace to drive multi-stakeholder collaboration. You thrive in a fast-paced environment with many cross-functional interactions thanks to your excellent communication, organizational and accountability skills. Qualifications and desired skills include:
Ph.D. in a scientific or engineering discipline and 8+ years of experience or M.S. or 10+ year- experience in MSAT or manufacturing of cell and gene therapies (preferred), vaccines or biologics.
Proven track record of 4+ years of managerial success motivating, influencing, resolving conflict and managing stakeholders
Demonstrated ability to lead investigations, risk assessments, tech transfer, process monitoring, and routine clinical support; experience with process characterization, PPQ and PV is highly desirable.
Understanding of QbD approaches and implementation of creative problem solving
Robust knowledge of US and EU cGMP regulations/guidances
Embrace the core Intellia values of One, Explore, Disrupt, Deliver to make gene-editing therapies a reality, today
Meet your future team
You will join the growing, collaborative and passionate Tech Ops team and have a key role in CMC lifecycle management as we advance our ex vivo (CT) and in vivo (VV) pipeline products using CRISPR genome-editing technologies. As Head of MSAT, you will build your team from the ground up to support cell therapies and viral vector technologies. In this key leadership role, you will report to the Vice President, Cell Therapy and Viral Vector Process Development, who embraces a culture of trust, respect and collaboration so that each team member can reach their full professional and personal potential.
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.