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Associate Director, Late-Stage Process Development/MSAT
2 months ago
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 wantall ofour 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:
In this role, you will join the Nucleic Acid Therapeutics Process Development and Manufacturing (NTDM) Team, within the Technical Operations department to help develop and transform genome editing therapeutics into products. The particular NTDM group you will be joining is responsible for process development and technical GMP manufacturing oversight (MSAT) for synthetic oligonucleotides as well as lipid excipients and small molecules for in vivo & ex vivo programs. This is a leadership role where you will represent the team in cross-functional discussions and contribute to pre-clinical to late-stage technical strategy including process validation and regulatory interactions.
Additional responsibilities include:
Oversee internal process development strategy and activities upstream/downstream for oligonucleotides (e.g. sgRNA)
Shape vision for sgRNA development and define Intellia’s sgRNA synthesis and screening processes across modalities, scales and modification pattern.
Create sustainable internal workflows and processes that align with best industry practice for oligonucleotide preparation regarding quality control for research grade materials (raw materials, equipment, operations)
Coordinate process analytical efforts and inform process analytical strategy.
As required, develop, implement and/or establish novel processes and processes for novel modalities (RNA, DNA) or advance existing processes towards stage-appropriate GMP manufacturing
If applicable, oversee technology transfer and GMP manufacturing activities (incl. late-phase) for oligonucleotides
Own Process Change Management (change controls), generate process risk assessments and development reports as well as Quality documentation as required.
Support external Process Characterization and Process Validation activities through technical assessments and strategy evaluation. Drive timelines and scope and align with cross functional team to address technical and regulatory risks.
Work with analytical development, non-clinical and regulatory functions to enhance impurity profiling and late-stage impurity control strategies for oligonucleotide products.
Prepare and review CMC documentation for IND’s and BLA’s (Module 3) and support regulatory interactions and response to regulatory questions (RtQs). Participate in regulatory CMC strategy development, providing input in support of regulatory submissions required for clinical trial and marketing applications.
Manage projects and activities in a matrixed environment and/or manage own team of scientist and engineers to achieve CMC goals. Train and mentor scientists and engineers focused on formulation, process development, MSAT and process/product characterization efforts.
About You:
Our ideal candidate will have a PhD in Chemical or Biomedical Engineering, Chemistry or related field, with 6+ years of experience or a MS with 10+ years of experience in process development within a biotech or pharmaceutical company. If you describe yourself as a team player who wants to help drive curative therapies to the clinic and beyond, we encourage you to apply Other desired skills include:
Experience with process development and GMP manufacturing processes for nucleic acids, and/or LNPs and its components.
Experience in scale-up, process development, process characterization, and process validation for late-stage products.
Experience with regulatory submissions and processes including query management.
Must be a strong technical writer and presenter with experience in writing technical documents, reports, and risk assessments.
Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team).
Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team.
Meet your future team:
The Nucleic Acid Therapeutics Process Development and Manufacturing (NTDM) Team is a group of highly skilled, energetic scientists and engineers who are excited about bringing potentially curative therapeutics to the world. Our team is responsible for developing robust, scalable, and innovative manufacturing processes to advance clinical programs, as well as supporting the in vivo and ex vivo emerging pipelines. In this role, you will report to the Senior Director, NTDM. Your future team helps drive technology from research all the way to commercial stage. We enjoy progressing our programs and technical knowledge, but we also foster an environment for career growth as scientists and engineers in the biopharmaceutical industry. Apply today to join our team—we look forward to working together
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Covid-19 Vaccination Policy:All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
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.
