Principal Scientist/Associate Director – Drug Product Analytical Development

Omega Therapeutics is a development-stage biotechnology company pioneering a new class of programmable, mRNA-encoded therapeutics to transform human medicine. The OMEGA Epigenomic Programming™ 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. 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 validated novel DNA-sequence-based epigenomic targets we have mapped to 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 Principal Scientist / Associate Director, Drug Product Analytical Development (commensurate with experience) to join our Drug Product Analytical Development team.  This leadership position will be responsible for leading analytical method development for Omega’s mRNA-based lipid nanoparticle drug product therapeutics from research to the clinic.  They will work closely with Research, Drug Substance Analytical Development, DS & DP Process Development, and Quality Control to develop novel release and characterization methods, transfer of methods to contract labs or contract manufacturing organizations for GMP testing, and drafting of CMC sections and supporting documents for regulatory filings.  They will manage all aspects of the drug product analytical development lab to ensure reliable internal testing is performed, including the management of methods, SOPs, protocols and method development reports.  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 on a fast-paced scientific team.

Key Responsibilities:

• Lead a group of scientists to fully develop analytical methods that robustly characterize our mRNA-based lipid nanoparticle drug products
• Create analytical understanding to support robust clinical and ultimately commercial supply of all our platform products
• Develop a team with the abilities manage testing of multiple programs and continually advance the technology
• Design, execute, and document analytical method development in support of process development, product release, stability, and product characterization of mRNA therapies
• Ensure standard operating procedures, analytical test methods, and analytical sampling plans meet the highest industry standard
• Assure appropriate laboratory controls for sample management, data integrity, reagents, and equipment
• Review and approve method development and qualification reports
• Work with internal and external (CMO and CRO) laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
• Work cross-functionally and ensure a collaborative work environment with client groups, including Research, Process Development, Quality Control, and Manufacturing teams
• Work cross functionally to develop phase-appropriate specifications for DP
• Author, review and approve IND, IMPD, BLA and MAA sections; participate in scientific advice preparations and meetings

Required Qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry, Biology with 5+ years of industrial experience OR MS with 10+ years of industrial laboratory experience
• Prior experience with mRNA and/or liposome/lipid nanoparticle (LNP) formulation characterization and release testing required; knowledge of drug product potency assays is preferred
• Experience leading complex, multi-disciplinary projects and teams during biotech drug development
• Advanced hands-on experience with various analytical techniques including UPLC/HPLC, Sequencing, ELISA, qPCR, Western blot, SDS page, particle size, and compendial test methods
• Strong understanding of Design of Experiments (DOE) and QbD is a plus
• Ability to lead a team of scientists to develop comprehensive analytical understanding of products in pre-clinical and clinical development
• Experience preparing technical documents for internal distribution or inclusion in CMC or regulatory filings
• Knowledge of QbD approaches to analytical method development including risk assessment, DOE, and statistical analysis
• Ability to function efficiently and independently in a changing environment
• Well organized and ability to coordinate testing for numerous clinical candidates at multiple contract sites
• Demonstrated creativity and problem-solving skills
• 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
• Multitask and able to adjust workload based on shifting priorities