Senior Process Engineer I, LNP Manufacturing

3 months ago

Cambridge, United States Intellia Therapeutics Full time

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:

As a Senior Process Engineer I, you will join the LNP Process Sciences group, where we develop lipid nanoparticle (LNP) formulations to deliver curative CRISPR gene editing therapeutics. This role presents a unique opportunity to lead the efforts of bringing curative gene editing therapies to patients who need them, specifically in contributing to the manufacturing of material supporting clinical trials. The responsibilities of the role will include process development and validation for the LNP process, person-in-plant support for LNP production, and potential laboratory work as needed to support process development activities.

  • Oversee the manufacture of LNP drug products and CRISPR-Cas9 drug substance molecules at external CDMOs.

  • Collaboration with CDMOs and person-in-plant work supporting tech transfer, Phase 1 clinical material generation, and Phase 3 pivotal trial material leading into process validation campaigns.

  • Review executed master batch records, change orders, quality documents, and other external documentation received from CDMOs.

  • Work with External Manufacturing and Supply Chain to update program teams on material supply

  • Engage other members of the LNP Process Science team to work on continued manufacturing technology improvements and novel process development.

  • Perform hands-on work in the LNP process development laboratory as needed to support process improvement and characterization.

  • Contribute to authoring of regulatory documentation to support clinical trials.

  • Position may require up to 10% domestic/international travel.

    About You:

  • BS in Life Sciences, Chemical or Biological Engineering with 8+ years of industry experience OR

MS in Life Sciences, Chemical or Biological Engineering with 6+ years of industry experience OR

PhD in Life Sciences, Chemical or Biological Engineering with 1+ years of industry experience

Experience with phase-appropriate GMP manufacturing and processes, e.g., working at a CDMO or working with a CDMO as a client

Experience in scale-up, process development, process robustness, and process validation.

Experience with drafting, reviewing, and analyzing master batch records

Preferably have prior experience with LNP formulations with nucleic acids

Preferably have prior experience working with a frozen or lyophilized particle-based drug product.

Preferably have experience with Container Closure Integrity Testing and understanding of CCI principles

Ability to work independently, as well as part of a team in a fast-paced and highly dynamic environment

Excellent spoken and written communication skills

Strong leadership skills and experience in drug product development

Meet Your Future Team:

The LNP Process Sciences group is an ambitious and motivated team supporting production of Intellia LNP, as well as development and validation of the LNP production process. You will report to the Associate Director, LNP Process, and work 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, offering ample opportunities for cross-functional collaboration and growth.

#LI-KO2

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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