Senior Process Engineer/Senior Scientist, Downstream Process Development

Location
Cambridge, MA, United States
Posted
Mar 31, 2021
Ref
5161302002
Required Education
Other
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 Senior Process Engineer/Senior Scientist (commensurate with experience) to join our Process Development & Production team. The successful candidate will lead downstream mRNA drug substance process development for lead clinical and pre-clinical progress. 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:
  • Lead process development, transfer and characterization for mRNA drug substances, creating a robust process for scaling up production and purification of mRNA
  • Create mRNA process development pilot lab and pipelines to enable scalable mRNA production and characterization for all uses of mRNA at Omega (uses include discovery biology and platform projects, pre-manufacturing process development)
  • Design and execute experiments through proper DoE method toward improvement and optimization of mRNA production processes to ensure consistent and compliant 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
  • Manage and mentor junior scientists, comfortably leading line function in a team-first environment

Required Qualifications:
  • PhD in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related disciplines with a minimum of 2+ years of related industry experience or MS with 5+ years or BS with 7+ years
  • Prior experience with mRNA drugs substance manufacturing (or other forms of nucleic acids) is needed
  • Experience with mRNA in-vitro transcription, column chromatography (IEX, HIC, oligo-dT), tangential flow filtration (TFF) and filtration systems is a must
  • Demonstrated experience with drug substance process development, troubleshooting and scale-up of complex unit operations; a history of technical transfer of operations is preferred
  • 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
  • Experience with CMC section for pre-IND and IND submission to the FDA
  • 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