About Omega Therapeutics:
Omega Therapeutics is a privately held, development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, known as Omega Epigenomic Controllers. Using these epigenomic controllers, Omega is seeking to transform the practice of human medicine through highly selective and direct control of the human genome to treat and cure disease.
Omega Therapeutics leverages its pioneering Epigenomic Programming™ platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators and has identified and classified thousands of genomic “zip codes” across the ~15,000 IGDs as new drug targets. Omega’s new class of medicine, called Omega Epigenomic Controllers™, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company’s product candidates to also drug previously ‘undruggable’ targets across a broad range of diseases.
The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including certain oncology indications, liver disease, serious inflammatory conditions, and acute respiratory distress syndrome (ARDS) among others. Omega’s mission is to deliver the transformative therapies of tomorrow.
About the Role:
Omega Therapeutics, Inc. is seeking a highly innovative Principal Scientist, Drug Delivery and Formulation to join our growing Technical Operations team. Reporting to the Head of Drug Delivery and Formulation, this role will design and execute formulations and processes for Omega Epigenomic Programming platform products. The ideal candidate will have a strong background in drug formulation technical development and optimization, including lipid nanoparticles (LNP). The position will manage projects within a broad transcription modulation platform. S/he will be responsible for strategizing and conducting pre-formulation and formulation DOE studies, determining leading formulations for clinical trials, and managing early-stage formulation samples from preparation, to stability storage, to distribution for testing and data analysis. This leader will collaborate with interdisciplinary teams within drug development to develop and manage timelines, key deliverables, data reporting and strategy design to achieve Omega’s company-wide initiatives.
- Build and lead the lipid nanoparticle (LNP) formulation & process development team of research associates and scientists to produce, characterize and optimize LNP production
- Establish a toolset to support LNP process development (including high throughput screening technologies and mixing systems for robust scale up to clinical production)
- Drive fundamental improvement of LNP synthesis understanding towards enhancements and simplification of LNP formation
- Align mRNA LNP process development with an emphasis on formulation definition, process robustness, scale-up, and stability
- Lead the generation of preclinical LNP material generation
- Design experimental plans with managerial guidance
- Establish understanding of state-of-the art lipid nanoparticle research
- Partner cross-functionally to execute, characterize and/or implement fit-for-purpose, formulation, and process development
- Participate in performing formulation process development with Tangential Flow Filtration and biophysical characterization (light scattering, particle characterization) of lipid nanoparticles, lipids and mRNA
- Prepare CMC sections related to formulation and drug product development
- Experience in mRNA/Lipid Nanoparticles (mRNA/LNP) formulation and analytical development
- Experience with preparation of regulatory documents including FDA (BLAs, INDs, briefing documents) and EMA (CTD, MAA) and ICH Guidelines
- Extensive hands-on experience in the development of novel formulations technologies
- Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE)
- Strong analytical, problem solving and critical thinking skills
- Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform management of key updates and challenges
- Collaborative, communicative, and passionate about working with lipid nanoparticles leading to mediate the next generation of genetic medicines
- Bachelor’s degree in life sciences, analytical chemistry, or related field with 8-10+ years’ experience in the Biotech/pharma industry (advanced degree preferred)
- In-depth track record of understanding and experience of RNA containing LNP synthesis and processing
- Understanding of lipid chemistry, lipid modifications, lipid synthesis, and standard analytical techniques for macromolecules
- Technical understanding and experience in biopharmaceutical process manufacturing operations including industry cGMP environment and tech transfer to CMO/CRO
- Experience with high-throughput process development techniques and statistical design of experiments (DoE) strongly preferred
- Available to travel if/when needed