Manager, External Manufacturing & Supply Chain

Location
Cambridge, MA, United States
Posted
Sep 18, 2020
Ref
1182850205
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Summary:

The Manager of External Manufacturing & Supply Chain will be responsible for ensuring clinical supply to our patients for our lead programs and establishing and maintaining a comprehensive Materials Management program to support internal cGMP manufacturing. The successful candidate will help build the External Manufacturing & Supply Chain function at Intellia by implementing phase-appropriate tools and best practices.

Responsibilities:
    • Manage all clinical supply chain activities across assigned programs; responsibilities include management of relationships with clinical contract partners executing the transportation, brokerage, storage, label and pack and distribution of supply to clinical trial sites
    • Establish and maintain a comprehensive Materials Management program to support internal GMP Manufacturing of clinical trial material
    • Support the build and implementation of an electronic product traceability and chain of identity/chain of custody/chain of condition system for Intellia's cell therapy programs
    • Represent External Manufacturing & Supply Chain on Clinical Operations Program Teams and CMC Project Teams; partner with Clinical Operations, Regulatory, Quality, Procurement, Finance, Legal and other functions as needed to achieve program goals
    • Identify and escalate business critical risks impacting supply and/or timelines with related mitigations and/or possible solutions
    • Contribute to the authoring of regulatory submissions
    • Create area Standard Operating Procedures (SOPs) as required


Qualifications:
    • Bachelor's Degree in Life Sciences, Business, Supply Chain or related area
    • At least 8 years' experience in the biotechnology/pharmaceutical industry with a minimum of 2 years of experience in a GMP supply chain environment
    • Demonstrated project and team leadership skills
    • Experience with cell and gene therapy supply chain planning and materials management preferred
    • Ability to act in a complex and rapidly changing business environment


#LI-KO1

What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .