Director, CMC Team Technical Leader

Location
Cambridge, MA, United States
Posted
Jul 27, 2021
Ref
R253
Discipline
Science/R&D, CMC
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
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 CMC Team Technical Leader, you will lead the cross-functional team responsible for defining and executing the CMC strategy for Intellia's in vivo clinical asset(s). In this role, you will report to the SVP of Technical Operations and Quality, and will
  • Lead the cross-functional team that establishes the strategic CMC Development Plan for your asset(s)
  • Establish team goals and ensure operational plans are in place to execute on the strategic CMC plan
  • Drive decision making across all functions on the CMC team
  • Represent the CMC team in the Corporate Program Team and the CMC Governance Committee
  • Identify and escalate key issues and risks to the Technical Operations and Quality Leadership Team and the CMC Governance Committee
  • Be the main point of contact for CMC topics with Health Authorities for your asset(s)
  • Ensure preparation of all relevant CMC documents that support Module 3 authoring and act as the technical reviewer of Module 3 for your asset(s)


About You:

Do you enjoy working in a highly team-oriented and fast-paced role? We're looking for someone with strong leadership and communication skills who thrives in a dynamic, collaborative environment. Our ideal candidate has experience in biopharmaceutical development of cell and gene therapy products, with an aptitude for strategic thinking and cross-functional team leadership. Other role requirements include:
  • Advanced degree (MS, Ph.D. or equivalent) in the life sciences, chemical, biochemical or biological engineering
  • 10+ years industry experience with >2 years demonstrated cross-functional team leadership
  • Experience ranging from entry of new products into the clinic, phase appropriate process and analytical development, process validation, BLA/MAA submissions as well as post-approval changes as technical or CMC team leader
  • Prior CMC team leadership experience in Cell & Gene Therapy is desirable
  • Thorough understanding of drug development, including knowledge of relevant regulations


Meet your Future Team:

In this role, you will report to the SVP of Technical Operations and Quality and will be a member of the Tech Ops & Quality Leadership Team. We are a diverse group of leaders with a range of backgrounds and collective experiences that make us stronger as a team and enable us to learn from each other. There is no road map for what we are doing as leaders in the systemic delivery of in vivo CRISPR-Cas9 therapies while offering a full spectrum approach to create CRISPR-Cas9 therapy via our ex vivo pipeline. We thrive on charting new territory, exploring new ways to drive our programs and the business forward, while promoting and cultivating the culture of ONE that has made, and continues to make, Intellia such an incredible place to work. We look forward to fostering your skills, strengthening our leadership through learning from your experiences, and working together as ONE to transform the lives of people with severe diseases by developing curative genome editing treatments.

#LI-KO1

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.