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) Project Manager, CMC (CMC PM) has experience in the use of project management tools (MS Project/Smartsheet) and principles and has the ability to manage activities for multiple project teams from preclinical through clinical development. The CMC PM will ensure projects stay on track and are within expected timelines, lead and support cross functional project teams and work closely with CMC and functional leads to develop and maintain CMC plans. The candidate will also coordinate cross-functionally to ensure appropriate integration with broader project/program timelines and CMC strategy and manage strategic external relationships, tracking timelines and deliverables. The CMC PM role requires a strong communicator, able to identify risks and escalate issues as required.
Responsible for CMC documentation including but not limited to: agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
Identify and define risks, mitigations and/or contingency plans. Execute scenario planning and risk assessments, providing options for teams.
Act as point of contact for research, operations and G&A functions
Ensure project progress and upcoming deliverables are understood by the CMC team and provide updates to management.
Support management of strategic external relationships by aligning internal and external requirements/resources to achieve timelines, milestones, and deliverables.
Create and update near- and long-term project plans with clearly defined goals. Assure on-time completion of tasks or milestones assigned to support project plans.
Report project/program status into governance meetings with CMC or functional lead(s) and Program Manager, as appropriate.
Support preparation and management of CMC program budget(s). Act as point of contact for SOWs and contracts management.
Train new staff on select techniques & topics as an SME.
Actively manage CMC Stability studies.
Bachelor’s degree in the life sciences (molecular biology a plus), chemical or industrial engineering, or equivalent required. MS in science a plus. PMP certification desirable.
At least 8 years’ experience in the biotechnology/pharmaceutical industry with at least two years project management experience in a CMC environment.
Knowledge of biotechnology/pharmaceutical product development process including manufacturing process, comparability/feasibility studies, stability studies, analytical development, regulatory filings, and clinical/commercial operations.
Demonstrated proficiency in project management tools e.g. Smartsheet, MS Project, Think-cell and budgeting templates.
Proficient at prioritization and driving complex programs to milestone completion.
Ability to identify risks and escalate appropriately.
Strong communication skills both written and orally. Able to communicate CMC program 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.