Associate Director, Product Technical Lead (Oligonucleotides and Small Molecules)

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Job description

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 leadership role, you will be joining the Small Molecule and Oligonucleotide Process Sciences team as part of the Technical Operations department, to develop and transform genome editing development candidates into therapeutic products. The team is responsible for process development, process validation and GMP manufacturing oversight (MSAT) for synthetic oligonucleotides as well as lipid excipients and small molecules associated with Intellia's in vivo & ex vivo program assets. You will be the Product Technical Lead (PTL) for Oligonucleotides and Small Molecules, representing the team in cross-functional discussions and contributing to late-stage technical strategy including process validation as well as regulatory interactions.

Additional responsibilities include:

• Coordinate and support Process Validation activities across modalities and assets. Transition processes to commercial stage and lead/track continuous process verification for sgRNA and lipids.
• Build system for process validation documentation and proceduralize process validation efforts across modalities. Lead process validation subteam.
• Support regulatory authoring across regions and lifecycle stages. Prepare and review CMC documentation for INDs and BLAs (Module 3) and support regulatory interactions and response to regulatory questions (RtQs). Participate in regulatory CMC strategy development.
• Establish and oversee process development strategy for new modalities and technologies in order to support clinical development and commercial supply.
• Develop and implement strategy for tracking and trending of process performance to enhance predictability and inform process development and process strategy.
• Support process evolution and change management through planning efforts and risk/return assessments.
• Support technology transfer and establishing of new GMP manufacturing operations for oligonucleotides and small molecules, as applicable.
• Work with analytical development, non-clinical and regulatory functions to enhance impurity profiling and late-stage impurity control strategies for oligonucleotide products.
• Manage projects and activities in a matrixed environment to achieve CMC goals. Train and mentor scientists and engineers focused on process development, MSAT and process/product characterization efforts.
• Develop intellectual property, publish scientific papers and other tasks related to the Company's scientific and business interests.
• Support CMC teams and subteams as Product Technical Lead and SME as needed.

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 BS/MS with 11+ 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 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 Oligonucleotide and Small Molecule Process Sciences Team is an experienced, highly motivated, and lively group, with an innate curiosity to learn and advance Intellia's assets to commercial stage. The Small Molecule Process Sciences Team is focused on critical activities with Technical Operations (CMC), including sgRNA and lipid manufacturing, process development and process validation. While a growing team of currently about 10 team members, you will interface with the broader Process and Analytical Development (PAD) team.

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.

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