Scientist, Potency Assays

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 Potency Assay Scientist to work on our gene and cell therapy clinical programs. The candidate must have a strong background and hands-on experience in cell-based potency assays as well as binding/immunoassays. The successful candidate will take a leading role in defining, developing and optimizing new potency assays, as well as facilitating method transfers, qualifications and validations. He/She will be responsible for analytical development, qualification and operational support for preclinical through late stage clinical development programs for Intellia Therapeutics.

Responsibilities:

• Develop, optimize and in-house qualification of cell-based bioassay/potency assays and characterization assays with 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
• Knowledge of GxP regulations
• Author and review SOPs, development reports, 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, Process 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
• Maintain well documented records of analytical data, laboratory notebooks, execution of assays and stability data

Qualifications:

• PhD degree in Cell biology, Biochemistry, or related disciplines with minimum 2+ years of experience; Master's 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
• Excellent communication, technical and organizational skills are required
• Managerial experience desirable
• Critical thinking, troubleshooting and attention to detail is a must. Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method improvements
• In depth knowledge of understanding the mechanism of action (MOA) of biologics and experience in design, and development of mechanism of action (MoA) reflective bioassays using appropriate technologies, such as cell-based, ELISA and enzymatic assays experience is required
• Prior experience or technical knowledge in molecular assays such as qPCR, ddPCR and NGS is desirable
• FACS experience is desirable
• 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 is essential
• Extensive experience in cell culture, cell line development is required
• Must be able generate SOPs and technical reports with appropriate level of detail, as well as perform bioassay assay trending
• Must have experience working with CROs
• Good understanding of statistical methods/tools for data analysis is strong plus
• Team player, good interpersonal and organizational skills

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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.