Senior Quality Control Associate
- Employer
- Intellia Therapeutics
- Location
- Cambridge, MA
- Start date
- Jan 24, 2022
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- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
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
We are excited to welcome this new member to our growing QC team and company. In this role you will have the opportunity to support the stability and reference standard programs. By engaging with our external clients, you will move products through clinical development. If you are organized and have a strong attention to detail, this is the role for you. You will act as the interdepartmental liaison to cross-functional groups including Analytical Development and Quality Assurance. As the Senior Associate, you will work on various projects including:
- Perform review of QC stability data in support of GMP clinical trial material in compliance with SOPs. Compile and trend stability data and reports. Update regulatory submission content.
- Coordinate internal and external testing activities including sample management and shipments.
- Track work orders, purchase orders, and invoices, to ensure continuity of testing.
- Initiate and author technical memos, change controls, deviations, and CAPAs.
- Assist in the implementation and maintenance of general lab operational systems in accordance with GxP compliance to maintain functionality.
- Serve as the cross-functional team member for assigned projects.
About You:
You will have a bachelor’s degree with a minimum of 4-6 years’ GMP lab experience. Experience conducting testing and reviewing QC data in support of GMP. Knowledge of a variety of methods, including but not limited to: HPLC, UV, CE, Bioassay, gel electrophoresis, and compendial testing. Technical writing experience including creating, revising, and reviewing SOPs, protocols, reports, technical assessments, and technical memos. Knowledge of the use and interpretation of pharmacopeias such as USP/NF, EP, and JP. Knowledge and experience with electronic systems such as EDMS, LIMS, etc. preferred. You will be detail oriented with the ability to manage multiple, competing priorities. Strong verbal and written communication skills.
Meet your future team:
The Quality Control team is a self-motivated and lively group, with an innate curiosity to learn. The QC department supports release and stability testing for GMP products throughout the product life cycle. This QC role interacts with QC and QA on a daily basis as part of the expanding Quality team. We are moving to a hybrid working model, by working at home and together in our Cambridge offices.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. 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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