Senior Manager, CMC Operations

Cambridge, MA, United States
Mar 18, 2021
Required Education
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.

The (Sr) Manager, CMC Operations will coordinate oversight and compliance of Intellia Process and Analytical Development Labs and provide sample management, logistics and coordinate analytical testing for samples and materials in support of internal and external process development. The (Sr) Manager, CMC Operations has experience in the use of project management tools (MS Project/Smartsheet) and principles and has the ability to manage and prioritize activities for multiple project teams from preclinical through clinical development to ensure projects stay on track and are within expected timelines. The candidate will also coordinate cross-functionally to ensure appropriate integration with broader project/program timelines and CMC strategy, tracking timelines and deliverables.


Laboratory Coordination:
  • Serve as primary point of contact for Lab Operations and IT to assist with lab relocation(s), and restructuring.
  • Develop, implement and maintain laboratory guidelines and standard operating procedures.
  • Develop and coordinate equipment maintenance and calibration program.
  • Track and manage inventory of long-lead process consumables and critical reagents for process development and pilot scale production.

Sample and Materials Management:
  • Manage and track development samples and materials inventory.
  • Lead coordination of non-GMP analytical sample testing and prioritization.
  • Manage logistics of non-GMP sample and materials transport between process development, analytical testing labs, CROs and external partners.
  • Review and approve SOWs for external process development sample testing.

Additional Responsibilities:
  • Responsible for documentation including but not limited to: agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
  • Support preparation and management of CMC budget(s). Act as point of contact for SOWs and contracts management.

  • Bachelor's degree in the life sciences (molecular biology a plus), chemical or industrial engineering, or equivalent required. MS in science a plus.
  • At least 8 years' experience in the biotechnology/pharmaceutical industry.
  • Prior experience in lab operations desired.
  • Proficient at prioritization and driving complex projects to milestone completion.
  • Ability to identify risks and escalate appropriately.
  • Strong communication skills both written and orally. Able to communicate project status in a clear and concise manner.
  • Experience working both independently and in a cross functional, team-oriented, collaborative high-pressure environment, is essential.
  • Strong leadership skills (persuasive, encouraging, and motivating).
  • Ability to work within a rapidly changing environment and to quickly adapt to new situations.

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.