Senior Project Manager, CMC

Location
Cambridge, MA, United States
Posted
Sep 08, 2020
Ref
438449573
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 (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 leads to develop and maintain CMC plans. The candidate will also coordinate with the Head of CMC Project Management and Program Management to ensure appropriate integration with broader 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.

Responsibilities:
    • 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.
    • 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 program status into governance meetings with CMC lead and Program Manager, as appropriate.
    • Support preparation and management of CMC program budget(s).
    • Train new staff on select techniques & topics as an SME.
    • Actively manage CMC Stability studies.


Qualifications:
    • 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.


#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 .