Senior Scientist/Scientist, Upstream Process Development

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 Senior Scientist / Scientist (commensurate with experience) to join our Process Development & Production team. The successful candidate will lead upstream process development, including plasmid design, plasmid production and mRNA production. The ideal candidate will have a strong understanding of process optimization, scalable processes, technical transfer, GMP compliance and Regulatory submissions (i.e. pre-IND, IND). Additionally, the role will be responsible for process robustness/characterization studies, understanding product quality and helping to refine the product control strategy.

We are looking for enthusiastic, detail oriented, and highly motivated individuals with a passion for bringing novel medicines to patients and who are comfortable working on a fast-paced scientific team.

Key Responsibilities:

• Create and maintain a plasmid process development pilot lab to enable scalable plasmid production and characterization in support of discovery biology and platform projects, pre-GMP manufacturing process development
• Perform basic to complex activities in seed train, fermenter operation, harvest/clarification activity and purification of plasmid DNA in a commercial cGMP environment
• Participate in the strategic design of plasmid and mRNA constructs
• Optimize mRNA production to provide enhanced quality and potency attributes
• Design and execute experiments through proper DoE method toward improvement and optimization of plasmid and mRNA production processes
• Define and execute studies to identify critical process parameters through QbD, ensure robust process performances
• Critically review and analyze data, communicate results, present findings and draft technical reports
• Support development of standard operating procedures, technology transfer activities and documentation in support of regulatory filings

Required Qualifications:

• D. in Biochemistry, Molecular Biology, Biomedical Engineering or related discipline with 3+ years of laboratory experience or M.S. with +5 years of laboratory experience
• Experience with plasmid DNA manufacturing processes is strongly preferred
• Demonstrate experience with process development and scale-up of complex unit operations
• Prior experience with mRNA (or other forms of nucleic acids) production & purification is needed
• Experience with molecular biology techniques related to strain development and synthetic biology (PCR, gene cloning, primer design, bacterial transformation and cell culture)
• Knowledge of fermentation, metabolic engineering techniques and/or microbial metabolic pathways is a plus
• Familiar with statistical software such as JMP for both manufacturing process analysis as well as statistical experiment design
• Understanding of cGMP requirement and ICH guidelines
• Demonstrates creativity and problems solving skills
• Able to work independently as well as part of a team
• Organized, detail oriented, self-starter who always seeks for improvements
• Ability to multitask and adjust workload based on shifting priorities
• Effective verbal and written communication skills