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 is seeking a highly motivated and talented Director/Associate Director, Drug Product Manufacturing (commensurate with experience) to join our growing Technical Operations team.  This role will be responsible for the company’s all cGMP drug product manufacturing operations to ensure the delivery of Omega’s portfolio of products. They will be responsible for driving strategies and technical and operational management of drug product manufacturing operations at Contract Manufacturing Organizations (CMOs). They will have a strong background in scale-up, manufacturing and fill finish operations of nanoparticle-based drug products. They will oversee Omega’s drug product CMOs to ensure reliable execution with the highest compliance, quality, and regulatory standards to meet program and company goals. The incumbent contributes to investigations and batch release activities to ensure timely delivery of drug product to ensure uninterrupted clinical supply.  They will work closely with internal functions, principally process development, drug substance manufacturing, quality, supply chain and program teams, to achieve company and program objectives.  As Omega prepares for substantial growth, this role will need the skills, experience, and maturity to work effectively in a dynamic, cross-functional, growing organization.

Key Responsibilities:

  • Overall responsibility for technical and operational management of manufacturing and fill finish operations for lipid nanoparticle formulation materials supporting clinical studies and eventual transition to commercial supply
  • Provide guidance and direction for manufacturing strategy, goals, budgets, and other operational activities to ensure timely delivery of drug product materials to meet program and company goals  
  • Integrate internal and external team activities into the manufacturing operations and present plans and progress to the Executive Leadership Team
  • Oversee hiring to build an effective drug product manufacturing team; create and communicate a clear vision among direct reports, effectively align resources, and motivate teams to achieve goals
  • Manage drug product CMOs for manufacturing operations, technology transfers, investigations, and batch documentation reviews and responsible for continuous improvement and operational excellence at CMOs
  • Responsible for identification and selection of CMOs for cGMP manufacture and supply of clinical trial materials for development programs
  • Author regulatory and technical documents for regulatory submissions in support of drug product manufacturing and serve as subject matter expert in regulatory interactions
  • Maintain a high level of safety, compliance, and efficiency to drive the organization to world-class manufacturing standards

 Required Skills:

  • Proven ability to attract top talent and to build the manufacturing team with an inspiring vision for the organization
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of the organization
  • An entrepreneurial approach to develop new, innovative ideas that will drive growth within the Manufacturing organization
  • The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
  • Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to the executive leadership
  • Develop effective and efficient working relationships with both internal and external partners
  • Available to travel if/when needed

Required Qualifications:

  • Bachelor’s degree in life sciences, engineering, or related field; advanced degree (MS, PhD or MBA) preferred
  • Experience with lipid nano particles (LNP) manufacturing and scale-up is required
  • A minimum of 10+ years of manufacturing operations experience in the biopharmaceutical/pharmaceutical industry covering drug product operations
  • Complete understanding of tech transfer, cGMP and global regulatory requirements
  • Demonstrated experience supporting technology transfers and cGMP manufacturing operations at third party manufacturers required
  • Experience with authoring and reviewing regulatory filings is required

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