Senior Process Engineer, Formulation and Drug Delivery

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 skilled and motivated Sr. Process Engineer (commensurate with experience) to join our Formulation and Drug Delivery Sciences team. The successful applicant will have a strong background in scale-up, process development and manufacturing of nanoparticle-based drug products. The candidate will focus on developing and implementing scalable and robust processes related to the formulation of lipid nanoparticles (LNPs) with nucleic acids. In addition, the role will help lead late-stage drug product development activities for lead pre-clinical and clinical programs through process robustness/characterization studies, understanding product quality and helping to refine the product control strategy. In addition, this unique opportunity will allow for a significant role in developing the next generation of drug delivery technology to enable Omega's first-in-class epigenetic controllers.

Key Responsibilities:

• Design and execute experiments related to process improvements and optimization of lead Lipid Nanoparticle formulations
• Develop a scalable and compliant manufacturing process and define process control strategy to identify critical process parameters
• Lead experiments to confirm process robustness
• Explore, develop and scale-up novel drug product processes
• Characterization of final nanoparticle formulations in conjunction with Analytical Sciences
• Interact with internal and external groups to manufacture and supply formulations for pre-clinical, GLP-tox and early-phase clinical studies
• Prepare technical reports and presentations as it relates to process optimization and scale-up to support technology transfer activities
• Write and review protocols and batch records for drug product processes
• Author IND filings/regulatory documentation
• Develop intellectual property, publishing scientific papers and other tasks related to the company's scientific and business interests

Required Qualifications:

• BS in Life Sciences, Chemical or Biological Engineering, or related field, with 10+ years, Masters with 7+ years, or PhD with 2+ years of industry experience
• Comprehensive know-how and direct experience of different pump systems, TFF, fluid flow and mixing dynamics in formulation processes is a must
• Experience designing, executing and analyzing particle-based drug delivery systems
• Demonstrated experience with process development and scale-up of complex drug products
• Working knowledge of Quality systems, GMP-related requirements and regulatory requirements for CMC and ICH guidelines is desirable
• Preferably has prior experience with LNP formulations with nucleic acids
• Preferably has prior experience working with a frozen or lyophilized particle-based drug product
• Demonstrates creativity and problem-solving skills
• Ability to work independently, as well as part of a team
• Organized, detail-oriented, and a self-starter who continuously seeks to improve existing laboratory methods and processes.
• Effective verbal and written communication skills