Product Technical Lead

2 weeks ago

Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time
About the Role

We are seeking an experienced Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team within Technical Operations. 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.
About You

We are looking for a highly motivated and experienced individual 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.

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.
About Intellia Therapeutics, Inc.

Intellia Therapeutics, Inc. is a biotechnology company focused on developing curative genome editing treatments for severe and life-threatening diseases. We are committed to a diverse and inclusive environment and are an equal opportunity employer.

We are a growing company with a strong culture of innovation and collaboration. Our team is passionate about making a difference in the lives of patients and is dedicated to delivering high-quality results.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Join our team and be part of a dynamic and innovative company that is changing the face of medicine.

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