Senior Director, Process Development and Analytical Sciences

Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA™ 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. Using a suite of technologies, paired with Omega’s process of systemic, rational and integrative drug design, 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  mapped and validated proprietary and novel DNA-sequence-based epigenomic loci, EpiZips™ to durably 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 Senior Director, Head, Process Development and Analytical Sciences (PDAS) who will be reporting to the SVP,  Technical Operations and Quality. This role will be responsible for leading both process and analytical development activities for mRNA-based drug substance and lipid nanoparticles-based drug product. They will be responsible for driving CMC strategies and  technical development of drug substance and drug product processes. This role will ensure the reliable execution of process development with the highest quality and regulatory standards to meet program and company goals.  They will work closely with internal functions, principally R&D, Manufacturing, Quality and Supply Chain and Program teams, to achieve company and program objectives. They will hire, lead and develop the PDAS team to successfully meet group objectives. This person will join the leadership team of Technical Operations and play a significant role in building the organization as the company continue to scale and grow. As Omega prepares for substantial growth, the Sr. Director, PDAS will need the skills, experience and maturity to work effectively in a dynamic, cross-functional and growing organization.

Key Responsibilities:

• Overall responsibility for process and analytical development of Omega’s platform products supporting pre-clinical, clinical studies, and eventual transition to commercial supply
• Provide leadership in development, characterization, and scale-up of the upstream and downstream manufacturing processes to produce mRNAs and LNPs for Omega platform products
• Provide technical leadership to analytical development team supporting mRNA drug substance and LNP drug product
• Provide science-based approach to process steps development and optimization to improve consistency and robustness
• Required to author and/or review regulatory submissions and provide technical input to regulatory discussions
• Will serve as a mentor and coach to CMC personnel, modeling behaviors and leadership aligned with our company values
• Responsible for managing the PDAS team with hire, train and coach staff
• Provide guidance and direction for development strategy, goals and budgets for PDAS
• Oversee hiring to build an effective PDAS team; create and communicate a clear vision among direct reports, effectively align resources, and motivate teams to achieve corporate goals

 Required Skills:

• Proven ability to attract top talent and to build the PDAS 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 PDAS organization
• 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 & issues to the executive leadership
• Develop effective and efficient working relationships with both internal and external partners

Required Qualifications:

• An Advanced degree (MS, MBA, PhD) in life sciences, engineering, or related field
• Several years of leadership progression/experience within process and analytical development in the biopharmaceutical/pharmaceutical industry
• Experience with plasmid, mRNA and LNP manufacturing related processes and scale-up is required
• Strong grasp and application of fundamentals pertaining to process development, tech transfer, and process validation activities
• Ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationship
• Experience in managing and working with CDMO/CMOs
• Available to travel if/when needed