- 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 Intellia
- Represent Technical Operations in the ex vivo emerging pipeline program team
- Partner with business development for evaluation of potential business opportunities, assessing project plans and their feasibility
- Manage process Tech Transfer activities from Process Development to Manufacturing
- Define and establish the Control strategy for cell therapy and viral vectors manufacturing.
- Implement bioprocess development methodologies, including QbD development concepts and statistical DoE approaches
- Contribute to CMC strategy and capabilities in cell therapy and viral vector process development
- Develop CMC documentation to support regulatory filings
- Participate in vendor management and qualification visits as needed
- Act as subject matter expert for regulatory and partner/customer inspections
- Hire, lead and develop employees to successfully meet group objectives
- Degree in Biology; Chemistry; Chemical or Bioengineering; BS or MS with 15 years’ experience or Ph.D. and 10 years’ experience
- Direct experience with and cell therapy process development and viral vector drug substance process development
- Direct 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 bioprocessing
- Experience with viral vector downstream process development including ultrafiltration/diafiltration, tangential flow filtration, ion exchange chromatography, affinity chromatography, size exclusion chromatography, and sterile filtration
- Experience with optimizing, scaling up/scaling out and tech transferring manufacturing processes
- A thorough understanding of quality by design (QbD) principles and practical experience implementing them
- Experience operating in early and mid-stage clinical development environment
- 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 and effectively communicated at all levels of the organization.
- Ability to work and thrive in a fast paced, rapidly changing environment
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.