Principal Scientist, Cell Therapy Process Development

Location
Cambridge, MA, United States
Posted
Dec 16, 2020
Ref
L393
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Job Description:

Intellia is seeking a motivated Process Development candidate for a T cell Principal Scientist position to join our Cell Therapy Technical Operations team. The primary responsibilities for this position include driving platform development of allogeneic T cell therapy, focusing heavily on T cell selection. In addition, this position will require experience with leading process technology transfer to CDMO. As well, this position will involve collaborating with internal and external partners to form process characterization plans, process-related risk assessments, new technology evaluations, and manufacturing support. The ideal candidate has familiarity with both TCR and CAR-T related cell therapies.

Responsibilities:
  • Lead development and optimization activities to establish a selection and enrichment platform for allogeneic T cell therapies, considering Quality by Design and closed systems.
  • Evaluate and identify key performance parameters through hands-on process development pursuits.
  • Establish a scalable allogeneic T cell process for gene editing using CRISPR tools and both non-viral and viral template delivery within a cross-functional team.
  • Aid in technology transfer of allogeneic T cell process to CDMO, including review of protocols, MBRs, and reports, aligning with quality assurance expectations.
  • Coordinate and/or participate in characterization of T cells during process development activities, partnering with analytical development.
  • Directly supervise and provide training to junior process development team members, including experimental design oversight.
  • Provide high quality data driven decision making within the CMC team and participate in strategic program discussions.
  • Work effectively with independence and in collaboration with colleagues in support of program goals, communicating findings in a concise and timely manner.

Qualifications:
  • PhD in Biochemistry, Biology, Biological Engineering, or Immunology with 5+ years hands-on experience, or master's degree with 11+ years.
  • Demonstration of aseptic cell culture, closed system process tools, and cryo-banking techniques are required. A candidate with CRISPR/gene editing experience would be preferred.
  • Proficient in drafting Master Batch Records and Standard Operating Procedures for associated process equipment
  • A thorough knowledge of immunology and experience with T cell receptor diversity.
  • The ability to work effectively with management, process development, and supply chain to aid in sourcing reagents, evaluating multiple vendors to inform process decisions.


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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.