Director/Associate Director, Quality Control

Cambridge, MA, United States
Apr 30, 2021
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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 Director/Associate Director, Quality Control ( commensurate with experience) to join our Technical Operations team. Reporting to the VP and Head, Technical Operations, this role leads a team responsible for establishing, implementing, and managing quality control activities within the organization and across a network of external labs used for the testing of Omega's portfolio of products. This role will develop and implement the strategy for product and raw material quality control management systems and tools for early-stage clinical products and eventually for commercial products and oversee quality control (QC) of drug substance and drug product testing at CTLs and CMOs with the highest compliance, quality and regulatory standards to meet the program and company goals.

Key Responsibilities:
  • Oversee quality control (QC) of drug substance and drug product testing at CTLs and CMOs with the highest compliance, quality and regulatory standards to meet program and company goals
  • Implement continuous QC improvement initiatives to drive quality systems and tools to ensure maximum productivity across the organization
  • Establish specifications, stability testing and batch release activities to ensure timely delivery of drug substance and drug product
  • Author/Review QC related regulatory and technical documents for regulatory agency submissions and serve as subject matter expert in regulatory interactions
  • Ensure that internal processes and metrics are aligned; build and strengthen quality control systems and determine the appropriate infrastructure and resources required to achieve business objectives
  • Facilitate root cause analysis and drive robust actions to ensure elimination of root cause for GMP operations
  • Hire, train, mentor and retain QC team; plan, direct, and monitor work activities such that goals and objectives are accomplished efficiently, completely, within established timeframes and in compliance with department SOPs and cGMP regulations

Required Skills:
  • Complete and advanced understanding cGMP requirements for clinical manufacturing and global regulatory requirements; of GMP/GLP and global regulatory requirements
  • Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the 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
  • Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership
  • Familiarity with testing of mRNA and lipid nanoparticle (LNP) materials is preferred
  • Experience with authoring and reviewing clinical regulatory filings
  • Experience in quality oversight of CTLs and CMOs for analytical testing is required
  • Experience in leading, training and root cause analysis and effective investigation practices

Required Qualifications:
  • Bachelor's degree in life sciences, analytical chemistry, or related field. Advanced degree (MS or PhD) preferred.
  • A minimum of 10+ years of leadership experience in all aspects of QC including analytical method development, validation, method transfers, release specification establishment and stability program management
  • Advanced understanding of all relevant GMP standards including knowledge of global regulatory requirements
  • A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners
  • Available to travel if/when needed