Lead, Quality Control

Company: Intellia Therapeutics
Location: Cambridge
Posted on: November 16, 2021

Job Description:

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 a new member to our growing QC team and company. In this role you will drive activities related to testing performed at contract organizations for gene editing products for Drug Substance and Drug Product. You will support externally sourced projects, quality events, and documentation related to the assigned contract organizations. If you are organized, communicate well and have a strong attention to detail, this is the role for you. The individual will act as interdepartmental liaison to various groups, including Analytical Development, Manufacturing, and Quality Assurance. As the QC Lead, you will work on various projects including:

• Primary support of batch release, test methods, and new product implementation (method transfer and qualification)
• Perform data review, statistical analysis, and trending.
• Conduct assessments of laboratory investigations and quality system events, including authoring deviations, CAPAs, and change controls.
• Troubleshoot and provide additional technical support for method, material, and instrument-related issues.About You:You will have a minimum of Bachelor's degree in a scientific field with 8+ years of experience (M.S. with 5+ years) in a GMP products. Experience managing vendors is key.Strong technical understanding of analytical techniques for RNA and LNP products, for example, chromatography, PCR, bioassay and compendial testing.Experience with electronic Quality systems ( e.g. LIMS, EDMS).Knowledge with the use and interpretation of guidance's including ICH, USP/NF, EP.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 Lead role interacts with other QC portfolio teams and QA as part of the expanding Quality team. 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.

Keywords: Intellia Therapeutics, Cambridge , Lead, Quality Control, Other , Cambridge, Massachusetts