Senior Director / Director, Manufacturing

About the Role:

Omega Therapeutics, Inc. is seeking a highly motivated and talented Senior Director / Director, Manufacturing who will be reporting to the Head of Technical Operations. The Senior Director / Director, Manufacturing is responsible for the company's all cGMP manufacturing operations to ensure the delivery of Omega's portfolio of products. S/he is responsible for driving strategies and technical and operational management of drug substance and drug product manufacturing operations at Contract Manufacturing Organizations (CMOs). S/he oversees Omega's 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 substance and drug product to ensure uninterrupted clinical supply. S/he hires, leads, and develops the manufacturing team to successfully meet group objectives. Works closely with internal functions, principally process development, quality, supply chain, and program teams, to achieve company and program objectives. This incumbent joins the Leadership Team of Technical Operations and plays a significant role in building the organization as the company continues to scale and grow. As Omega prepares for substantial growth, the Sr. Director/Director, Manufacturing 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 operations for drug substance and drug product 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 substance and drug product materials to meet program and company goals
• As a senior leader in the Technical Operations Team, 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 manufacturing team; create and communicate a clear vision among direct reports, effectively align resources, and motivate teams to achieve goals
• Manage drug substance and 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
• Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support company objectives
• Author regulatory and technical documents for regulatory submissions in support of 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

Qualifications:

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

Skills and Capabilities:

• 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 an 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