Sr. Director / Director, Head of Drug Delivery and Formulation

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 Head of Drug Delivery and Formulation ( commensurate with experience) to join our growing Technical Operations team. Reporting to the VP and Head, Technical Operations, this role will lead the design, development and implementation of novel formulations for Omega's Epigenomic Programming platform products. S/he will be responsible for defining strategies, executing empirical studies, and managing the technical and operational aspects of our drug delivery technology. The ideal candidate will be an experienced leader with a strong background in drug formulation technical development and optimization, including lipid nanoparticles (LNP). The position will provide leadership to projects within a broad transcription modulation platform. 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.

Key Responsibilities:

• Design strategies for developing formulations and drug product for preclinical, and clinical studies
• Deliver products and processes from developability screening of R to D transition molecules all the way through technology transfer to drug product CMOs, and eventual technical support for commercial products
• Responsible for developing and executing innovative (LNP and non-LNP) drug delivery platforms and strategies
• Author and oversee preparation of technical reports, data summaries and CMC related documents required for regulatory submissions
• Identify collaborators, CROs, and state-of-the-art new technologies to further develop Omega's pipeline
• Build and maintain effective partnerships with internal and external key stakeholders and CROs to ensure high quality and on-time execution
• Represent Drug delivery and Formulation team on multidisciplinary project teams, working collaboratively to ensure project progression
• Collaborate in a fast-paced, interdisciplinary team environment with all disciplines of drug development (i.e., discovery research, nonclinical development, process and analytical development, regulatory and clinical) to ensure formulation as key aspect of compound optimization and candidate selection
• Work with research teams to develop fit-for-purpose early formulations to support in vitro and in vivo (pharmacology, DMPK) studies
• Manage and mentor the growing Formulation and Drug Delivery team, including resource planning, budgets, staff development, and performance management

Required Skills:

• Demonstrated ability to lead, build and manage an innovative and collaborative team
• Established in using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile
• A proven track record in developing, characterizing and scaling up lipid nano particle (LNP) formulations for systemic administration from pre-clinical through late-stage development
• Extensive hands-on experience in the development of novel formulation technologies
• Ability to assess the formulation and process technologies landscape to effectively employ enabling formulation technologies or unique delivery systems
• Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE)
• Experience as primary author of relevant sections of INDs and other regulatory documents
• Strong analytical, problem solving and critical thinking skills
• Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership

Required Qualifications:

• Graduate degree in life sciences, analytical chemistry, or related field with 15+ years' experience in the Biotech/pharma industry (advanced degree preferred)
• A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment
• Experienced leader and scientist with a strong background in novel formulations, including lipid nanoparticles (LNP) vehicles.
• Available to travel if/when needed