Manager, External Manufacturing

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.

Job Description:

Intellia is growing! We are seeking a Manager of External Manufacturing manage relationships with key Contract Manufacturing Organizations (CMOs). In this newly created role, you will build and lead cross-functional teams to ensure delivery of program milestones. The successful candidate will help build the External Manufacturing function at Intellia by implementing phase-appropriate tools and best practices.

Responsibilities:

• Serve as the primary contact and relationship manager to assigned CMOs; responsibilities include managing contract setup and negotiation, budget establishment and adherence, production planning, operational execution and on time and in full delivery of program deliverables
• Lead cross-functional External Manufacturing Teams with membership from Process Development, Analytical Development, Quality, Regulatory, CMC Project Management, Supply Chain, Procurement and Finance; manage Team priorities at the CMO based on Intellia's needs across programs
• Monitor CMO performance using a set of standard KPIs and report progress to management by leading Quarterly Business Reviews with the External Manufacturing Team
• 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, Engineering, 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 manufacturing environment
• Demonstrated project and team leadership skills
• Experience with cell and gene therapy manufacturing preferred
• Ability to act in a complex and rapidly changing business environment

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.