Position Summary:
Orbital is seeking a highly skilled and motivated Scientist to join the RNA Process Development team in Cambridge, MA. The RNA Process Development team works to develop, characterize, and implement robust preclinical & clinical manufacturing processes to support Orbital’s exciting pipeline of products. From preclinical through clinical manufacturing, the RNA PD team is accountable for process development, characterization, and scale-up as well as technology transfer. The focus of this role will be supporting the RNA process and program progression through planning and executing studies in the laboratory, and the authoring of protocols, reports, and regulatory documentation.
Responsibilities:
- Perform all Manufacturing, Science & Technologies (MSAT) functions associated with process characterization, transfer, and support for synthesis and purification steps in RNA manufacturing.
- Design and execute detailed experiments using risk assessments, appropriate scale-down models, Quality by Design (QbD) principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.
- Author and review technical protocols, reports, assessments, and regulatory sections as required in support of Investigational New Drug (IND) and marketing application submissions.
- Effectively work with CDMO partner(s) to enable successful tech transfer and scale-up activities.
- Collaborate with internal research & development functions to support the progression of Orbital’s RNA pipeline.
- Support CDMO partner in authoring & reviewing quality documents (e.g. change control, CA/PA) and performing activities for lot release (assess deviations and process changes).
- Perform process monitoring including manufacturing/process data summary, analysis, and presentation.
- Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables.
Qualifications:
- B.S. (8+ years), M.S. (6+ years) or Ph.D. (1 year) in Biochemical Engineering, Biochemistry or related scientific disciplines with direct industry experience in RNA processes.
- Expertise in either synthesis or purification of RNA molecules with a strong understanding of unit operations is required.
- Exceptional laboratory skills and hands-on experience with bench-top equipment, bioreactors, FPLCs and UFDF skids including familiarity with current varieties and suppliers of consumables related to this equipment is required.
- Must have the ability to travel up to 10%.
- Experience with supporting large-scale manufacturing processes (RNA required), current Good Manufacturing Practices, and/or US / EU regulations is required.
- Must have experience in GMP technology transfer.
- Ability to perform data analysis using advanced statistics, including design of experiments (DoE) approaches leveraging statistical analysis software is highly preferred.
- Experience working in project teams with members from peer groups, CMC teams, R&D, CMOs and CROs is a strong plus.
- Experience with analytics and biophysical characterization such as HPLC, CE, & gel electrophoresis is highly preferred.
- Experience with mechanistic model development and computational fluid dynamics is a plus.
- Experience in Clinical manufacturing and process validation is a plus.
