Senior Scientist, Upstream Process Development

Location
Cambridge, MA
Posted
Sep 22, 2021
Ref
4124692004
Required Education
Doctorate/PHD/MD
Position Type
Full time

Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as 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. 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 novel DNA-sequence-based epigenomic loci 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 Senior Scientist (commensurate with experience) to join our Process Development & Production team. The successful candidate will lead upstream process development, including plasmid design, plasmid production and mRNA production.  The ideal candidate will have a strong understanding of process optimization, scalable processes, technical transfer, GMP compliance and Regulatory submissions (i.e. pre-IND, IND). Additionally, the role will be responsible for process robustness/characterization studies, understanding product quality and helping to refine the product control strategy.

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:

  • Create and maintain a plasmid process development pilot lab to enable scalable plasmid production and characterization in support of discovery biology and platform projects, pre-GMP manufacturing process development
  • Perform basic to complex activities in seed train, fermenter operation, harvest/clarification activity and purification of plasmid DNA in a commercial cGMP environment
  • Participate in the strategic design of plasmid and mRNA constructs
  • Optimize mRNA production to provide enhanced quality and potency attributes
  • Design and execute experiments through proper DoE method toward improvement and optimization of plasmid and mRNA production processes
  • Define and execute studies to identify critical process parameters through QbD, ensure robust process performances
  • Critically review and analyze data, communicate results, present findings and draft technical reports
  • Support development of standard operating procedures, technology transfer activities and documentation in support of regulatory filings
  • Ability to hire, retain, and mentor direct reports; lead performance reviews and align direct reports’ individual performance goals with the broader organization’s goals

Required Qualifications:

  •  Ph.D. in Biochemistry, Molecular Biology, Biomedical Engineering or related discipline with 3+ years of laboratory experience or M.S. with +5 years of laboratory experience
  • Experience with plasmid DNA manufacturing processes is strongly preferred
  • Demonstrate experience with process development and scale-up of complex unit operations
  • Prior experience with mRNA (or other forms of nucleic acids) production & purification is needed
  • Experience with molecular biology techniques related to strain development and synthetic biology (PCR, gene cloning, primer design, bacterial transformation and cell culture)
  • Knowledge of fermentation, metabolic engineering techniques and/or microbial metabolic pathways is a plus
  • Familiar with statistical software such as JMP for both manufacturing process analysis as well as statistical experiment design
  • Understanding of cGMP requirement and ICH guidelines
  • Demonstrates creativity and problems solving skills
  • Able to work independently as well as part of a team
  • Organized, detail oriented, self-starter who always seeks for improvements
  • Ability to multitask and adjust workload based on shifting priorities
  • Effective verbal and written communication skills