Associate Director, Product Technical Lead
4 weeks ago
Intellia Therapeutics, Inc. is a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to transform the lives of people living with these conditions by leveraging the power of genome editing.
Job SummaryWe are seeking an experienced Associate Director, Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team within the Technical Operations department. As a key member of our team, you will be responsible for developing and transforming genome editing development candidates into therapeutic products.
Key Responsibilities- 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.
We are looking for a highly motivated and experienced professional with 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. You should have experience with process development and GMP manufacturing for nucleic acids, and/or LNPs and its components, as well as experience in scale-up, process development, process characterization, and process validation for late-stage products.
You should also have experience with regulatory submissions and processes including query management, and be a strong technical writer and presenter with experience in writing technical documents, reports, and risk assessments. Additionally, you should have experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team).
Excellent organizational, documentation, and communication skills are essential, as well as adaptive learning, critical thinking, and the ability to work well in a team.
Meet Your Future TeamThe 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.
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Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout Intellia Therapeutics, Inc.Intellia Therapeutics, Inc. is a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases.We are driven by a single-minded determination to excel and succeed together, leveraging the power of curiosity and pushing boundaries to develop innovative solutions.Our...
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