Full-Time

Principal Scientist

Analytical Science

Posted on 6/3/2025

GenEdit

GenEdit

51-200 employees

Develops CRISPR gene therapy delivery systems

No salary listed

Daly City, CA, USA + 1 more

More locations: San Bruno, CA, USA

In Person

Category
Biology & Biotech (2)
,
Requirements
  • Bachelor’s degree in Chemistry or a related field with at least 12 years of experience
  • Master’s degree in Chemistry or a related field with at least 10 years of experience
  • PhD in Chemistry or a related field with at least 8 years of experience
  • Experience with key analytical techniques: NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC, MAL-SEC, and other characterization methods
  • Experience in the authoring and reviewing technical documents, analytical sections of commercial regulatory files and responding to analytical health authority inquiries
  • Strong technology and scientific background in the application of analytical chemistry to small molecule CMC
  • Advanced knowledge and understanding of cGMPs
  • Experience working in or with QC laboratories
  • Knowledge of analytical method development validation and transfer requirements
  • Experience with regulatory / analytical CMC requirements
  • Demonstrated ability to be SME for analytical trouble-shooting and problem-solving
  • Overall awareness of the pharmaceutical manufacturing & quality processes and regulatory requirements necessary to manufacturing and distributing
  • Basic understanding of polymer nanoparticle formulation and polymer manufacturing processes
  • Excellent written, verbal communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization
  • Work authorization in the US is required
Responsibilities
  • Provide analytical subject matter expertise in polymer characterization using various characterization method and overall lifecycle management of commercial release methods and specifications
  • Participate on cross-functional teams as the analytical SME
  • May lead a matrixed team of commercial analytical scientists
  • Collaborate with development teams to ensure analytical commercial readiness of late-phase projects (methods and specifications for the analytical overall control strategy)
  • Implement methods for polymer, drug products, process intermediates, and regulatory starting materials at commercial QC testing sites.
  • Lead method validations and validation gap assessments to ensure validations are up to current standards, perform method validation remediation, as necessary
  • Lead method transfer within in GenEdit or external QC laboratories for the purpose of globalization and lifecycle management (including bringing on new manufacturing sites)
  • Write formal analytical documents such as validation protocols/reports, method transfer protocols/reports and investigations reports
  • Provide expertise and guidance for problem-solving including method troubleshooting, laboratory investigations, deviations, and CAPA’s
  • Prepare and review analytical CMC sections of commercial regulatory submissions and address analytical-related inquiries from health authorities.

Preparing a concise company summary for GenEdit based on the provided description.

Company Size

51-200

Company Stage

Series B

Total Funding

$118.5M

Headquarters

Brisbane, California

Founded

2016

Simplify Jobs

Simplify's Take

What believers are saying

  • February 2026 Series B financed BRZ-101 through IND-enabling studies.
  • Genentech collaboration continues, supporting external validation and milestone revenue.
  • Sarepta collaboration demonstrated muscle delivery and neuromuscular disease relevance.

What critics are saying

  • BRZ-101 lacks human data, so first internal program remains unproven.
  • Partner revenue depends on Genentech and Sarepta continuing development milestones.
  • Moving into therapeutics increases cash burn beyond the $60 million Series B.

What makes GenEdit unique

  • NanoGalaxy uses proprietary polymer nanoparticles for non-viral CRISPR delivery.
  • Founded in 2016 at UC Berkeley, GenEdit built a polymer library.
  • Preclinical studies showed selective delivery of CRISPR-Cas9 ribonucleoprotein to target tissues.

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Benefits

Health Insurance

Flexible Work Hours

Paid Vacation

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

-3%
BreezeBio
Feb 25th, 2026
BreezeBio (Formerly GenEdit) Announces Series B Financing to Advance Internal Pipeline of Precision Genetic Medicines

BreezeBio (formerly GenEdit) announces Series B financing to advance internal pipeline of precision genetic medicines. February 25, 2026 - New therapeutics in development for autoimmune disease and oncology - Lead therapeutic BRZ-101 designed to restore immune tolerance in type 1 diabetes, advancing into IND-enabling studies - Expanding platform capabilities for NanoGalaxy(R), including targeted delivery for in vivo CAR SOUTH SAN FRANCISCO, Calif., February 25, 2026 - Breeze Bio, Inc., formerly known as GenEdit, today announced the close of $60 million in Series B financing to advance its first internal therapeutic programs toward the clinic and to continue expansion of the company's NanoGalaxy delivery platform. The new BreezeBio name reflects the company's momentum in translating powerful delivery technologies into practical, scalable genetic medicines with curative potential. "Now that we can deliver genetic payloads to the right cells with precision, we are building genetic medicines designed to make a real difference for patients," said Kunwoo (Ryan) Lee, Ph.D., Chief Executive Officer of BreezeBio. "We've completed our transition from a delivery platform to a therapeutics company, and this financing allows us to advance our first internal programs toward the clinic while continuing to expand the reach of NanoGalaxy." The company's lead therapeutic candidate, BRZ-101, is a novel immune modulation therapy designed to restore tolerance in type 1 diabetes. The therapy delivers autoantigens encoded by mRNA and tolerogenic co-factors to antigen-presenting cells, which in turn present the antigens to T cells in the context of tolerance. The process induces antigen-specific regulatory T cells (Tregs) that block the autoimmune response precisely without affecting the functioning of the immune system. In preclinical testing, BRZ-101 induced antigen-specific immune tolerance in multiple models of autoimmune disease, including the NOD mouse model of diabetes, and was well tolerated in mice and non-human primates. The company is advancing BRZ-101 into IND-enabling studies. "BreezeBio is solving one of the most significant challenges in gene therapy, targeted delivery, and in doing so is helping define the next generation of genetic medicines," said Vincent Jeong, Managing Director at Yuanta Investment, manager of the Ministry of Health, and lead investor in the Series B financing. "With platform validation through the company's strategic collaboration and milestone achievement with a global biotech partner and clear progress toward clinical development, BreezeBio is approaching an important inflection point as it advances a differentiated internal pipeline designed to address significant unmet needs in autoimmune and other serious diseases. We believe BreezeBio is positioned to become a global genetic medicines developer, and Yuanta is committed to supporting that journey." The engine for BreezeBio's therapeutic programs is the company's proprietary NanoGalaxy platform, which has demonstrated targeted delivery to the immune, cardiac, pulmonary, and central nervous systems based on the physiochemical properties of the polymers that encapsulate the payloads and form the nanoparticles. In addition, BreezeBio is expanding the platform with ligands conjugated to the nanoparticles for additional tissue and cell specificity, including delivery to T cells to enable in vivo CAR-T therapeutic development. In parallel with its internal programs, BreezeBio continues to advance its multi-year collaboration and licensing agreement with Genentech, a member of the Roche Group. Following the initial milestone achievement and associated payment last year, R&D activities under the collaboration continue to progress. The Series B financing is led by new investors, Yuanta Investment and DSC Investment, with participation from SV investment, Kiwoom Investment, STIC Ventures, Top Harvest Capital, and others. Existing investors, including DAYLI Partners, Pathway Investment, Loftyrock Investment, Korea Investment Partners, WOORI Venture Partners, KDB Silicon Valley, and ACVC Partners also participated. About BreezeBio BreezeBio is a biotechnology company developing genetic medicines enabled by precise, non-viral delivery across biologically relevant tissues. Using its proprietary NanoGalaxy(R) platform, BreezeBio engineers nanoparticles designed to deliver genetic payloads, including mRNA, to specific cell types, with demonstrated delivery to immune cells as well as select tissues in the heart, lung, and central nervous system. The company is advancing an internal therapeutic pipeline focused on autoimmune diseases and oncology, led by BRZ-101 to restore immune tolerance in type 1 diabetes. BreezeBio is headquartered in California in the South San Francisco area. For more information, visit www.breezebio.com. Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., [email protected]

BioPharma Dive
Feb 25th, 2026
BreezeBio raises $60M Series B to develop precision genetic medicines for autoimmune diseases

BreezeBio, a South San Francisco-based genetic medicines startup, has raised $60 million in a Series B round co-led by Yuanta Investment and DSC Investment. The company, formerly known as GenEdit, has refocused from developing delivery technology to creating its own treatments for autoimmune diseases and oncology. The startup's proprietary NanoGalaxy technology uses specialised polymer nanoparticles to deliver genetic cargo to specific organs with precision. BreezeBio has previously secured collaboration deals with Sarepta Therapeutics, Editas Medicine and Genentech. Its lead programme, BRZ-101, aims to suppress the autoimmune response in Type 1 diabetes by delivering blueprints for antigens that promote immune tolerance. The therapy is advancing into final preclinical studies this year before human testing begins.

Maekyung Media Group
Nov 14th, 2024
Korea's No. 1 Economic Media

GenEdit, a gene therapy development company, announced on the 14th that it has appointed Dr. Rodrigo Mora as its chief scientific officer (CSO) to expand the development of tissue-specific gene therapy using the Nano Galaxy platform.

MarketScreener
Jan 29th, 2024
Adverum Biotechnologies, Inc. Appoints Romuald Corbau as Chief Scientific Officer and Member of Executive Committee

Dr. Corbau joins Adverum from GenEdit, where he served as Chief Scientific Officer.

American Chemical Society
Jan 25th, 2024
GenEdit raises $24M, signs Genentech deal

The firm’s polymer nanoparticles will be used to target autoimmune disorders.

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