Senior Project Manager, CMC
Company: Intellia Therapeutics
Posted on: March 27, 2020
At Intellia, we are revolutionizing medicine by harnessing the
power of genome editing to develop potential cures. We bring new
hope for people living with conditions including cancer, genetic
disorders, viral infections, inflammatory disorders and many more.
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.
Coordinate with the Head of CMC Project Management and Program
Manager to ensure appropriate integration for broader program
timelines. Manage strategic external relationships, track timelines
and deliverables. 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
- Train new staff on select techniques & topics as an SME.
- Actively manage CMC Stability studies. Requirements:
- 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 (preferred), MS Project, and budgeting templates.
- Proficient prioritizing and driving complex programs to
- 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,
- Strong leadership skills (persuasive, encouraging, and
- Ability to work within a rapidly changing environment and to
quickly adapt to new situations. #LI-DG1 What Intellia Stands For:
At Intellia, our mission is to develop potentially curative genome
editing treatments that can positively transform the lives of
people living with severe and life-threating diseases. 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.
Keywords: Intellia Therapeutics, Cambridge , Senior Project Manager, CMC, Executive , Cambridge, Massachusetts
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