Senior Associate Scientist, Potency Analytical Development

Cambridge, MA, United States
Jan 14, 2021
Required Education
Masters Degree/MBA
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 Analytical Development candidate for a position as Sr. Associate Scientist/Associate Scientist to join our AD team. The individual will develop quantitative cell based assays measuring gene editing in target cells, and cell-based assays measuring the expression and the biological functions of specific genes. The successful candidate will play a leading role in facilitating method transfers, qualifications and validations for multiple clinical programs. He/She will be responsible for analytical development, qualification and operational support for preclinical through late stage clinical development programs for Intellia Therapeutics.

  • Develop, optimize and in-house qualification of cell-based bioassay/potency, and flow cytometry assays measuring gene editing, gene expression, gene function within established assay acceptance criteria for gene & cell therapy product characterization, lot release and stability testing
  • Technology Transfer: Act as SME in tech transfer of analytical methods, protocols/procedures and know-how from internal labs to external labs
  • Lab operation: Routine and non-routine analytical testing, coordination with internal/external PD or cGMP manufacturing on sample testing, maintain laboratory equipment, maintain laboratory sample inventory for potency assay, compile and present data to support process development and developmental stability studies
  • Evaluate novel assay technologies and methodologies that could improve existing analytical methods for potency assays
  • Compliant with GxP, keep good lab notebook and experiment records. Authoring and review of SOPs, Development Report, and assist in the preparation of CMC regulatory submissions
  • Assist in maintaining/qualification of critical reagent supply for assigned methods
  • Work collaboratively with Analytical Development and Quality teams to gather and analyze data to achieve method readiness.
  • Work closely with, and support quality control on investigations, OOS, OOTs and release assay trouble shooting

  • Masters degree with minimum 5+ years of experience; BS with minimum 10+ years of experience in biotech or pharma industry with primary focus on biologics and/or gene and cell therapy
  • Experience in development of cell-based potency assays
  • Experience in tech transfer of assays to CROs
  • Experience of flow cytometry-based assay development
  • Experience in analytical method development, qualification/validation
  • Experience in assay development for cell and gene therapy products highly desirable
  • Excellent communication, technical and organizational skills are required
  • Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired
  • Experience and knowledge of QC and GMP regulations
  • Must be able generate SOPs and technical reports with appropriate level of detail, as well as perform bioassay assay trending
  • Prior experience or technical knowledge in molecular assays such as qPCR, ddPCR and NGS is desirable
  • Good understanding of statistical methods/tools for data analysis is strong plus
  • Team player, good interpersonal and organizational skills


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.