Scientist / Sr. Scientist, Bio Analytical Sciences

Omega Therapeutics is a clinical-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, Inc. is seeking a Scientist / Sr. Scientist, Bio Analytical Sciences (commensurate with experience) to join our Nonclinical Team.  This person will support Discovery, Preclinical, and Clinical Development programs for bio analysis and will be responsible for developing and implementing PK and bio analytical strategy for programs, ensuring that PK and bio analytical support is completed in a timely, efficient manner and meets all current scientific and quality standards and adequately supports regulatory submissions.  This person must be a scientifically motivated self-starter, capable of working with minimal supervision and is enthusiastic, detail oriented with a passion for bringing novel medicines to patients and comfortable working within a fast-paced scientific team.

Key Responsibilities:

• Utilize significant scientific knowledge for design of bio analytical methods and algorithms to quantify the effect of LNP encapsulated RNAs on specific disease states both in Preclinical and Clinical areas
• Provide scientific and technical oversight to the bio analytical vendor for work performed at the CRO; manage assay development, transfer, troubleshooting, validation, and analysis of biological samples to support drug discovery & development for various candidates using LC-MS/MS, hybrid LC-MS/MS, qPCR, cell-based and ligand binding assays (ELISA, IHC) etc. at CRO
• Manage and resolve any problems or issues while keeping team and management informed of critical issues in a timely manner
• Responsible for ensuring reports are complete and accurate and meet regulatory filing requirements
• Responsible for preparing and/or providing input on Clinical/Non-Clinical regulatory documents including protocols, protocol amendments, reports, IBs, publications and presentations, and regulatory filings including IND etc., briefing books, and responses to questions from regulatory agencies
• Expected to advise teams and management continuously and proactively on the development and optimization of bioanalytical technologies, strategies and models to improve the quality and productivity of the function
• Will be a member of the Early Development/Nonclinical Safety group but will partner with colleagues in other functional areas such as Clinical Operations/Development etc. as needed to identify and manage external vendor support of GLP/GCP sample analysis
• Will also be required to stay current with the latest in technological and regulatory advances in the bio analytical realm

Required Qualifications:

• MS with 8+ years of experience or PhD with 5+ years of experience
• Strong expertise in FDA/EMA, GLP/GCP regulatory requirements and both Clinical & Non-Clinical bio analytical data management (both GLP and non-GLP) including data transferring, analysis, and reporting
• Prior experience with laboratory and vendor management is required
• Strong organization, multi-tasking and communication skills are key attributes of the successful candidate
• Individuals with regulatory writing experience in the context of bio analytical sciences, and having first-author, peer reviewed publications and/or presentations will be strong candidates for this role