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Head of Cell Therapy and Viral Vector Process Development

Company: Intellia Therapeutics
Location: Brookline
Posted on: September 8, 2020

Job Description:

At Intellia, we are revolutionizing medicine by harnessing the power of--genome editingto develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.We are seeking a highly motivated individual to join us as Sr. Director and Head of Cell Therapy and Viral Vector Process Development, reporting to the SVP of Technical Operations.-- The incumbent is responsible for the organization that designs and develops the manufacturing process and the control strategy to ensure robust, reliable and scalable clinical manufacturing processes for Intellia's cell therapy and viral vector platform programs.-- The successful candidate will be a self-starter who can work in a fast-paced environment, and who is willing and able to lead by doing.Responsibilities:Responsible for leading process development, optimization and scale-up activities for the manufacture of CRISPR/Cas9 edited T-cells and viral vectors for Intellia ex vivo and in vivo programs.Ensure availability of representative material to support pre-/non- clinical studies and CMC development (e.g. GLP tox material, Reference material, etc.)Facilitate cross-functional communication and drive strategic and operational alignment with program teams and functional leads across IntelliaRepresent Technical Operations in the ex vivo emerging pipeline program teamPartner with business development for evaluation of potential business opportunities, assessing project plans and their feasibilityManage process Tech Transfer activities from Process Development to ManufacturingDefine and establish the Control strategy for cell therapy and viral vectors manufacturing.Implement bioprocess development methodologies, including QbD development concepts and statistical DoE approachesContribute to CMC strategy and capabilities in cell therapy and viral vector process developmentDevelop CMC documentation to support regulatory filingsParticipate in vendor management and qualification visits as neededAct as subject matter expert for regulatory and partner/customer inspectionsHire, lead and develop employees to successfully meet group objectivesEducation/Experience:Degree in Biology; Chemistry; Chemical or Bioengineering; BS or MS with 15 years' experience or Ph.D. and 10 years' experienceDirect experience with and cell therapy process development and viral vector drug substance process developmentDirect experience with large scale close system cell processing equipment such as CliniMACS, Sepax, Rotea, Prodigy, and Xuri bioreactors is desirable.Experience with viral vector upstream process development including single use bioreactors, suspension adaptation of adherent cell lines, transfection, and seed train bioprocessingExperience with viral vector downstream process development including ultrafiltration/diafiltration, tangential flow filtration, ion exchange chromatography, affinity chromatography, size exclusion chromatography, and sterile filtrationExperience with optimizing, scaling up/scaling out and tech transferring manufacturing processes A thorough understanding of quality by design (QbD) principles and practical experience implementing themExperience operating in early and mid-stage clinical development environmentStrong written and verbal communication skills, including strong presentation skills. Intercultural experience and ability to act in a complex and rapidly changing business environmentAbility to facilitate conversations and drive towards decisions. Ability to influence and effectively communicated at all levels of the organization.Ability to work and thrive in a fast paced, rapidly changing environment#LI-KO1What 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.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.130 Brookline St. Cambridge, MA 02139 /Development - Technical Operations /Full-time

Keywords: Intellia Therapeutics, Brookline , Head of Cell Therapy and Viral Vector Process Development, Healthcare , Brookline, Massachusetts

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