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Cell Therapy and Viral Vector Process Development

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Head of Cell Therapy and Viral Vector Process Development Company: Intellia

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Head of Cell Therapy and Viral Vector Process Development AtIntellia, we are revolutionizing medicine by harnessing the powerof genome editing to develop potential cures. We bring newhope for people living with conditions including cancer, geneticdisorders, viral infections, inflammatory disorders and manymore.

We are seeking a highly motivated individual to join us as Sr.Director and Head of Cell Therapy and Viral Vector ProcessDevelopment, reporting to the SVP of Technical Operations. Theincumbent is responsible for the organization that designs anddevelops the manufacturing process and the control strategy toensure robust, reliable and scalable clinical manufacturingprocesses for Intellia’s cell therapy and viral vector platformprograms. The successful candidate will be a self-starter who canwork in a fast-paced environment, and who is willing and able tolead by doing.

Responsibilities: Responsible for leading process development,optimization and scale-up activities for the manufacture ofCRISPR/Cas9 edited T-cells and viral vectors for Intellia ex vivoand in vivo programs.

Ensure availability of representative material to supportpre-/non- clinical studies and CMC development (e.g. GLP toxmaterial, Reference material, etc.)

Facilitate cross-functional communication and drive strategicand operational alignment with program teams and functional leadsacross Intellia

Represent Technical Operations in the ex vivo emerging pipelineprogram team

Partner with business development for evaluation of potentialbusiness opportunities, assessing project plans and theirfeasibility

Manage process Tech Transfer activities from Process Developmentto Manufacturing

Define and establish the Control strategy for cell therapy andviral vectors manufacturing.

Implement bioprocess development methodologies, including QbDdevelopment concepts and statistical DoE approaches

Contribute to CMC strategy and capabilities in cell therapy andviral vector process development

Develop CMC documentation to support regulatory filings

Participate in vendor management and qualification visits asneeded

Act as subject matter expert for regulatory and partner/customerinspections

Hire, lead and develop employees to successfully meet groupobjectives

Education/Experience: Degree in Biology; Chemistry; Chemical orBioengineering; BS or MS with 15 years’ experience or Ph.D. and 10years’ experience

Direct experience with and cell therapy process development andviral vector drug substance process development

Direct experience with large scale close system cell processingequipment such as CliniMACS, Sepax, Rotea, Prodigy, and Xuribioreactors is desirable.

Experience with viral vector upstream process developmentincluding single use bioreactors, suspension adaptation of adherentcell lines, transfection, and seed train bioprocessing

Experience with viral vector downstream process developmentincluding ultrafiltration/diafiltration, tangential flowfiltration, ion exchange chromatography, affinity chromatography,size exclusion chromatography, and sterile filtration

Experience with optimizing, scaling up/scaling out and techtransferring manufacturing processes

A thorough understanding of quality by design (QbD) principlesand practical experience implementing them

Experience operating in early and mid-stage clinical developmentenvironment

Strong written and verbal communication skills, including strongpresentation skills. Intercultural experience and ability to act ina complex and rapidly changing business environment

Ability to facilitate conversations and drive towards decisions.Ability to influence and effectively communicated at all levels ofthe organization.

Ability to work and thrive in a fast paced, rapidly changingenvironment

What Intellia Stands For: At Intellia, our mission is to developpotentially curative genome editing treatments that can positivelytransform the lives of people living with severe and life-threatingdiseases.

We push boundaries. We are focused on positively disruptinghealth care treatment of patients with genomic diseases. The valueswe live by and drivers we look for are:

- One is respect for individuals; our unique qualities andstrengths; our own ways to understand, learn and improve. One isour single-minded determination to excel; to succeed together. Oneis you and us – trusting and counting on every single one ofus.

- Explore because we seek new ways to tackle disease. Explorewith unbounded minds…free from assumptions, open to ideas. Exploreby 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…withthat breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and yourdetermination to complete the task. Deliver by advancingrelentlessly and by maintaining high standards…even when nobody iswatching. Deliver by staying accountable and pulling your weight.Deliver because patients are counting on us to make the promisereality. Get it done.

POSITION: Full-Time, Exempt

EEOC Statement : Intellia believes in a diverse environment, andis committed to equal employment opportunity for all its employeesand qualified applicants. We do not discriminate in recruitment,hiring, training, promotion or any other employment practices forreasons of race, color, religion, gender, national origin, age,sexual orientation, marital or veteran status, disability, or anyother legally protected status. Intellia will make reasonableaccommodations for qualified individuals with known disabilities,in accordance with applicable law.

Intellia’s web-based application process is managed throughLever. Information submitted through application forms is collectedby Lever and subject to Lever’s privacy policy .

Keywords: Intellia, Cambridge , Head of Cell Therapy and Viral Vector Process Development, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Cell Therapy and Viral Vector Process Development, Other , Cambridge, Massachusetts

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