Lead Process Engineer, LNP Production

2 weeks ago

Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time
Why Choose Intellia Therapeutics, Inc.?

At Intellia, our mission is to pioneer transformative genome editing therapies that can significantly improve the lives of individuals facing severe and life-threatening conditions.

We are guided by our core values: One, Explore, Disrupt, Deliver. We believe that together, we can achieve extraordinary outcomes. Our culture fosters curiosity and innovation, encouraging us to challenge norms and create groundbreaking solutions. We understand the urgency of our work, as patients depend on us to turn our promises into reality, which drives us to uphold the highest standards and deliver results.

We aspire for our team members to exceed conventional limits. We are not just here to provide treatments; we are committed to finding cures and driving meaningful change. Imagine the incredible possibilities we can unlock together.

Your Role in Achieving More with Intellia:

As a Lead Process Engineer, you will be an integral part of the LNP Process Sciences team, focusing on the development of lipid nanoparticle (LNP) formulations essential for delivering innovative CRISPR gene editing therapies. This position offers a unique chance to spearhead initiatives that bring groundbreaking gene editing solutions to patients, particularly in the context of manufacturing materials for clinical trials. Your responsibilities will encompass process development and validation for LNP production, providing on-site support during LNP manufacturing, and engaging in laboratory activities as necessary to facilitate process development.
  • Supervise the production of LNP drug products and CRISPR-Cas9 drug substance molecules at external contract development and manufacturing organizations (CDMOs).
  • Collaborate with CDMOs and provide on-site support for technology transfer, generating Phase 1 clinical materials, and producing pivotal trial materials leading into process validation campaigns.
  • Review completed master batch records, change orders, quality documents, and other external documentation from CDMOs.
  • Coordinate with External Manufacturing and Supply Chain to keep program teams informed about material supply.
  • Engage with other members of the LNP Process Science team to drive continuous improvements in manufacturing technology and explore novel process developments.
  • Conduct hands-on work in the LNP process development laboratory as needed to support enhancements and characterization.
  • Contribute to the preparation of regulatory documentation to facilitate clinical trials.
  • This position may involve up to 10% domestic and international travel.
About You:
  • Bachelor's degree in Life Sciences, Chemical or Biological Engineering with over 8 years of industry experience OR
  • Master's degree in Life Sciences, Chemical or Biological Engineering with over 6 years of industry experience OR
  • Doctorate in Life Sciences, Chemical or Biological Engineering with at least 1 year of industry experience.
  • Proven experience with phase-appropriate GMP manufacturing processes, including working at a CDMO or as a client with a CDMO.
  • Expertise in scale-up, process development, process robustness, and process validation.
  • Experience in drafting, reviewing, and analyzing master batch records.
  • Preferably, prior experience with LNP formulations involving nucleic acids.
  • Preferably, experience with frozen or lyophilized particle-based drug products.
  • Preferably, familiarity with Container Closure Integrity Testing and principles of CCI.
  • Able to work independently and collaboratively in a fast-paced, dynamic environment.
  • Excellent verbal and written communication skills.
  • Strong leadership capabilities and experience in drug product development.
Meet Your Future Team:

The LNP Process Sciences team is a dedicated and driven group focused on supporting the production of Intellia's LNP, as well as the development and validation of the LNP manufacturing process. You will report to the Associate Director of LNP Process and collaborate within the broader Process and Analytical Development team. Our team works closely with counterparts in manufacturing and process development, including mRNA, sgRNA, and small molecules, providing numerous opportunities for cross-functional collaboration and professional growth.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to adhere to all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including vaccination for COVID-19.

EEOC Statement: Intellia is committed to fostering a diverse environment and ensuring equal employment opportunities for all employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices based on race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will provide reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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