Overview In this contract role in Cambridge, MA, you will develop and transfer analytical methods to support pharmaceutical material production and QC. You will work within a cross-functional team to apply advanced analytical principles across GC, HPLC/UPLC, and MS-based assays, helping ensure material quality and impurity control. The position focuses on method development, qualification, and transfer to suppliers, CMOs, and QC teams with external partners. This is a hands-on role shaping analytical strategy in a fast-paced life sciences environment.
Responsibilities- Develop, qualify, and transfer GC, HPLC, UPLC, and mass spectrometry-based assays for materials to suppliers, CMOs, and QC teams
- Identify impurity profiles and establish impurity limits
- Apply advanced scientific principles to process and analytical development
- Author and review method development/qualification reports, SOPs, and transfer/qualification protocols and reports
- Provide analytical support to internal teams and external partners
Key requirements- Advanced degree in Analytical Chemistry, Organic Chemistry, or a related field
- Expertise in chromatographic separation method development, qualification, and structure elucidation
- Strong knowledge of chromatographic separation mechanisms in gas and liquid phases
- Hands-on experience with HPLC, UPLC, and GC for molecule and isomer separation
- Background in organic chemistry with structure characterization using MS and NMR
- Familiarity with Waters and Agilent UHPLC and Mass Spectrometry hardware
- Experience with Empower, MassLynx, MassHunter, and Xcalibur CDS preferred
- Knowledge of peptide and/or oligonucleotide analysis is a plus
- HPLC/UPLC/GC method development
- Mass spectrometry
- NMR data interpretation
- Structure elucidation
- Impurity profiling
- SOP and report authoring
