Scientist / Sr. Scientist, Drug Product Analytical Development

 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 / Senior Scientist (commensurate with experience) with molecular biology/bioanalytics expertise, who enjoys developing robust and reliable analytical methods.

You will be directly involved with analytical method development activities to support Omega’s mRNA-based lipid nanoparticle drug product, from research to the clinic, through manufacturing.

As part of the Drug Product Analytical Development group, you will work closely with Research, Formulations, Drug Substance Analytical Development, Process Development, and Quality to develop novel release and characterization methods, assist in the transfer of methods for GMP testing, while generating documentation and reports to support regulatory filings.  You will be part of the team that ensures reliable internal testing is performed, including the generation and review of methods, SOPs, and protocols.

We are looking for enthusiastic, detail oriented, and highly motivated individuals with a passion for bringing novel medicines to patients and who are comfortable working in a fast-paced scientific team.

Key Responsibilities:

• Develop bioanalytical methods, including cell-based assays, that robustly characterize our mRNA-based lipid nanoparticle (mRNA-LNP) drug products
• Contribute to analytical understanding in support of robust clinical and commercial supply of all our platform products
• Design, execute, and document method development activities to support of process development, product release, stability (including clinical in-use), and characterization
• Follow and ensure standard operating procedures, analytical test methods, and analytical sampling plans meet the highest industry standard
• Follow laboratory controls for sample management, data integrity, reagents, and equipment
• Work with internal and external laboratories to assure robust method development, transfer, and execution in GLP and GMP settings
• Work independently and collaboratively with colleagues cross-functionally
• Critically review and analyze data, communicate results, and present findings
• Author, review, and approve reports and protocols
• Mentor and train members of the analytical development team

Required Qualifications:

• PhD in analytical chemistry, biochemistry, biology with 0-5 years of industrial experience OR MS with 5-8+ years of industrial laboratory experience OR BS with 8-10+ years of industrial laboratory experience
• Recent experience with cell-based assays and cell culture is required
• Prior experience with characterization, release, and stability testing of formulated nucleic acids (especially mRNA) in lipid nanoparticles (LNP) is highly valued
• Hands-on experience with various bioassay techniques such as sequencing, ELISA, qPCR, gels, and compendial test methods
• Strong understanding of Design of Experiments (DOE), QbD, and statistical analysis and their application to analytical method development is preferred
• Ability to function efficiently and independently in a changing environment
• Excellent communication skills, both oral and written
• Demonstrated ability in working with highly skilled teams in a fast paced, entrepreneurial and technical setting
• Confident, execution focused, team oriented, with an ability to thrive in an entrepreneurial environment
• A learner’s mindset with a commitment to personal growth and a drive to broaden technical skills and scientific knowledge
• Multitask and able to adjust workload based on shifting priorities while being well organized