Associate Director, Potency Analytical Development
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
As an Associate Director in Potency Assay Analytical Development, you will join the Analytical Development team within the Technical Operations group and embrace the opportunity to transform amazing sciences and technologies into powerful cures.
You will focus on leading a group of scientists in the development, troubleshooting, and qualification/validation of cell-based bioassays and immunoassays, for both gene and cell therapy-based programs, as well as the development of internal analytical capabilities to support in-house process development. To this end, you will be key in maintaining an evolving strategy across the cell and gene therapy platforms for early and late-stage potency assay development. You must have previous regulatory experience in filings and agency interactions. Responsibilities include:
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 AD and interact with a matrixed Tech Ops organization and other development teams to bring potency strategy forward
Lead the transfer of analytical methods internally or to contract laboratories; manage internal experiments and trend internal method performance and specifications
Lead potency 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
Assess method performance, 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.
Familiarity with late-stage potency validation and ICHQ14 is highly desired
Are you a motivated leader with organizational skills and drive? If you say yes, we encourage you to apply! Other qualifications and desired skills include:
Ph.D. in Biochemistry, Cell Biology, or a related field with 5+ experience in an industrial setting leading and managing a team
Experience working in a regulated pharmaceutical industry setting
Gene and/or cell therapy experience is strongly 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 guidance for the development, qualification/ validation of functional cell-based assays and potency methods
Meet your future team
The Analytical Development team is a group of Energetic, Brilliant, Fun and Motivated individuals. This group is responsible for developing robust and innovative analytical methods to support internal and external manufacturing processes. We support Intellia’s clinical programs as well as in vivo and ex vivo emerging pipelines. You will report to the Director of Bioassay and Potency within Analytical Development. She loves seeing people grow and develop and looks forward to learning from your experiences and building the team together.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.
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