Associate Director, Quality Assurance
- Employer
- Intellia Therapeutics
- Location
- Cambridge, MA
- Start date
- Sep 30, 2021
View more
- Discipline
- Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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.
How you will Achieve More with Intellia:
As Associate Director, Quality Operations, your responsibilities will include, but not be limited to:
support of CMC development teams in advancing Cell therapy/gene therapy drug candidates;
manage timely lot review/disposition of clinical GMP lots
identify, assess and manage risks; recommend mitigation strategies to quality management
represent Quality on External Supplier project team meetings
development, implementation and continuous improvement of procedures, ways of working.
support/manage investigations with potential to impact product quality/patient safety;
review IND, IMPD, BLA, MAA, RTQ’s, Briefing Books
support the accurate/on time development/approval/implementation of change management requests
About You:
Are you a people manager with a Bachelor’s degree in Sciences or Engineering, and 9+ years' biopharma experience? Does your experience include at least five years in Quality Assurance, and prior experience with cell/gene therapy/biologics? If this sounds like you, please consider applying for this role! To be successful in this role, strong written and verbal communication skills are essential. In addition, you'll leverage your leadership skills to innovate, collaborate, and strive for results.
Meet your future team:
You’ll be joining an exceptional team that collaborates with internal stakeholders and external partners to develop innovative therapies which bring hope to patients and their families. You will report to the Director, Quality Assurance. You’ll be supported as you bring your specific talents and suggestions to continuously develop our quality processes and ways of working to allow us to accelerate the progress of our clinical assets through development.
The team is currently working virtually. We do have plans to return to the Cambridge MA office in January 2022 (tentatively). Intellia has led the charge and designed a robust virtual onboarding experience since the start of the pandemic. Although in a virtual environment, the Quality team has made it a priority to continue to foster a sense of community among the group.
#LI-KD1
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.
Company
Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.
Change life stories with genome editing therapies!
Stock Symbol: NTLA
- Website
- http://intelliatx.com/
- Phone
- (857) 285-6200
- Location
-
40 Erie Street
Cambridge
Massachusetts
02139
United States
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