Associate Director, Potency Analytical Development

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 Associate Director or Principal Scientist to lead the Potency function in our quickly growing Analytical Development team within the Tech Ops organization. The primary responsibilities for this position will focus on leading a group of scientists in the development, troubleshooting, and qualification/validation of cell-based bioassays and immunoassays, as well as the development of internal analytical capabilities to support in house process development. This person will be key in building a strategy across the cell and gene therapy platforms for early and late stage potency assay development and have had previous regulatory experience both in filings and agency interactions.

Responsibilities:

• Lead, develop and mentor a group of scientists to effectively design, develop, optimize, transfer, qualify and/or validate novel cell-based bioassays and immunoassays for potency
• Draft and review SOPs, technical reports, and regulatory documents
• Represent the Analytical Development function on matrixed CMC and other development teams
• Lead the transfer of analytical methods internally or to contract laboratories; manage internal experiments and trend internal method performance and specifications
• Lead bioassay comparability testing to support process changes and transfers.
• Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences, including regulatory agencies
• Act as a technical resource in investigations, health authority inquiries and regulatory filings
• Maintain current knowledge of the field and area(s) of scientific expertise and development
• Assess method performance and identify issues and propose and implement appropriate remediation in conjunction with QA and company policies.
• Familiarity with statistical concepts and design of experiments (DoE) related to functional cell-based assay development, optimization, and validation.

Qualifications:

• Ph.D. in Biochemistry, Cell Biology, or a related field with 5 or more years of experience in an industrial setting
• Experience working in a regulated pharmaceutical industry setting
• Gene and/or cell therapy experience preferred
• Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g, ELISA, MSD, flow cytometry and cell based - proliferation, phosphorylation, reporter and cytotoxicity assays)
• Knowledge of GMP as relevant to laboratory practices in sample handling and analysis of GLP and GMP samples
• Knowledge of industry USP/ICH guidances for the development, qualification/ validation of functional cell-based assays and potency methods
• High competence in common software and data analysis packages (e.g., PLA software, SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools)
• Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team

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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.