About Omega Therapeutics:

Omega Therapeutics is a development-stage biotechnology company pioneering a new class of programmable, mRNA-encoded therapeutics to transform human medicine. The OMEGA Epigenomic Programming™ platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega’s engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of validated novel DNA-sequence-based epigenomic targets we have mapped to tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

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.  They will have a strong background in scale-up, process development and manufacturing of nanoparticle-based drug products. They will focus on developing and implementing scalable and robust processes related to the formulation of lipid nanoparticles (LNPs) with nucleic acids.  Additionally, they 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

 

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