Sr. Director, AAV & Cell Therapy Process Development And Manufacturing

Intellia Therapeutics Cambridge , MA 02138

Posted 3 weeks ago

At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to 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 AAV and Cell Therapy 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 AAV and T cell therapy 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 and optimization (upstream and downstream) and scale-up activities for AAV manufacturing; and leading the design, development and optimization of a functionally closed-system process for the manufacture of CRISPR/Cas9 edited T-cells.

  • Ensure availability of representative material to support pre-/non- clinical studies and CMC development (e.g. GLP tox material, Reference material, etc.)

  • Define and establish the Control strategy for AAV and engineered T cell manufacturing.

  • Implement bioprocess development methodologies, including QbD development concepts and statistical DoE approaches

  • Manage process Tech Transfer activities from Process Development to Manufacturing

  • Act as a subject matter expert to support Manufacturing during manufacturing campaigns (troubleshooting, Change Control/Deviation impact analysis, investigations etc.)

  • Contribute to CMC strategy and capabilities in AAV and cell therapy process development

  • Develop CMC documentation to support regulatory filings

  • Participate in vendor management and qualification visits as needed

  • Support supply chain management activities (Starting materials and Drug Substance)

  • Act as subject matter expert for regulatory and partner/customer inspections

  • Hire, lead and develop employees to successfully meet group objectives

Education/Experience:

  • Degree in Biology; Chemistry; Chemical or Bioengineering; BS or MS with 15 years' experience or Ph.D. and 10 years' experience

  • Direct experience with viral vector drug substance process development and cell therapy process development

  • Direct experience with upstream process development including single use bioreactors, suspension adaptation of adherent cell lines, transfection, and seed train bioprocessing

  • Direct experience with downstream process development including ultrafiltration/diafiltration, tangential flow filtration, ion exchange chromatography, affinity chromatography, size exclusion chromatography, and sterile filtration

  • Direct experience with large scale close system cell processing equipment such as CliniMACS, Sepax, Rotea, Prodigy, and Xuri bioreactors is desirable.

  • Experience with clinical scale AAV and cell therapy manufacturing equipment.

  • Familiarity with viral vector and T cells analytical testing and characterization methodologies

  • Experience with optimizing and scaling up/scaling out manufacturing processes and transferring those processes from to GMP manufacturing.

  • Proficiency using DOE tools

  • A thorough understanding of quality by design (QbD) principles and practical experience implementing them

  • Experience operating in early-stage clinical environments

  • Strong written and verbal communication skills, including strong presentation skills. Intercultural experience and ability to act in a complex and rapidly changing business environment

  • Ability to facilitate conversations and drive towards decisions. Ability to influence

  • Ability to work and thrive in a fast paced, rapidly changing environment

#LI-SV1

What 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 mindsfree from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

  • Disrupt by thinking courageouslyand creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughtswith 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 standardseven 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.


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Sr. Director, AAV & Cell Therapy Process Development And Manufacturing

Intellia Therapeutics