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.
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
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.