Senior Scientist, Analytical Development (On-Site)
Boston, MA
Our large biotech client is looking for someone to join their fast-growing team. This position requires a highly qualified and dedicated applicant who will work on the analytical team. The Senior Scientist of the Analytical Development Starting Material Group will be responsible for:
- Developing, qualifying, and transferring GC, HPLC/UPLC, and mass spectrometry-based assays for the identification, characterization, and impurity determination of critical starting materials and novel excipients for siRNA clinical products
- Developing strategies for impurity profiling of starting materials and excipients and supporting specification setting
- Collaborating with process development, manufacturing, quality assurance, and supply chain groups to ensure a continuous supply of starting materials and excipients at CMOs
- Supporting drug discovery and process development for new drug candidates entering development
- Investigating atypical/OOS results using GC/LC and mass spectrometry-based techniques
- Maintaining mass spectrometers and HPLC/UPLC instruments in the analytical development laboratories, which are conducted by contractors. The position requires approximately 75% hand-on bench work
The ideal candidate will have:
- A PhD in Organic/Medicinal Chemistry or Chemical Engineering with 3-5 years of work experience, preferably in an industrial setting
- Extensive experience in developing and qualifying analytical methods using HPLC/UPLC/LCMS/GC-based methods, and a thorough understanding of regulatory guidelines
- Prior experience in overseeing outsourced analytical work is an added advantage
- The ability to deliver innovative solutions and work in a fast-paced, deadline-driven environment while being able to adapt to changing priorities