Scientist, Analytical Development

Location
Cambridge, MA, United States
Posted
Aug 28, 2020
Ref
2019315353
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Intellia is seeking a motivated Analytical Development candidate for a position as Potency Assay Sr. Associate Scientist/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.

Responibilities:
    • 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


Qualifications:
    • PhD degree in Cell biology, Biochemistry, or related disciplines with minimum 2+ years of experience; 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


#LI-KO1

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 minds...free from assumptions, open to ideas. Explore by 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...with 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 standards...even 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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .