The Scientist role focuses on developing analytical methods for RNA therapeutics using HPLC and mass spectrometry, including documentation and troubleshooting.
Position Summary:
Orbital Therapeutics is seeking a skilled Scientist with experience in developing analytical methods to support the development and production of novel RNA therapeutics. The successful candidate will focus on chromatography and mass spectrometry methods and help develop and execute new assays to characterize RNA.
Responsibilities:
- Work as subject matter expert to develop new analytical methods to characterize RNA-based products and their delivery systems utilizing expertise in chromatography (HPLC/UPLC).
- Explore new techniques and technologies to provide analytical support of research and development at all stages.
- Participate in phase appropriate method transfer to third parties as necessary, including providing expertise and documentation (SOPs, technical reports, method qualification plans) to assist in method verification, qualification, and validation.
- Partner collaboratively with internal teams (process development, formulation development, research, preclinical manufacturing) to meet analytical development and routine testing needs.
- Lead, perform/guide troubleshooting when necessary.
- Oversee routine analytical testing and review data as well as perform routine testing when necessary.
- Operate and maintain HPLC and mass spectrometry instruments.
- Purchase and maintain analytical reagents and standards.
- Document and communicate results to team members and leaders.
- Approach analytical challenges creatively and help build up a cutting-edge analytical platform.
Qualifications:
- Ph.D. in Analytical Chemistry, Biochemistry or related discipline with 3+ years of CMC related experience; B.S./M.S. with appropriate years of experience will be considered.
- Strong experience analyzing various sample types using chromatography (HPLC/UPLC) in multiple separation modes (reversed phase, ion exchange, etc.) and associated detection methods is required, especially mass spectrometry (MS) and charged aerosol detection (CAD).
- Hands-on method development and impurity characterization experience with Thermo Orbitrap LC/MS system and associated software usage is highly desired.
- Experience with RNA/oligos, lipid nanoparticles, and/or proteomics is strongly preferred.
- Familiarity with GxP principles for development, documentation, qualification is preferred.
- Familiarity with early product development stage is preferred.
- Strong problem-solving skills and proven ability to work independently as well as in a team.
- Detail-oriented in assay execution and documentation.
Top Skills
Chromatography (Hplc/Uplc)
Mass Spectrometry (Ms)
Thermo Orbitrap Lc/Ms
Orbital Therapeutics Cambridge, Massachusetts, USA Office
100 Binney St, Cambridge, Massachusetts, United States, 02142
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