Analytical Development Scientist

Proclinical is seeking an Analytical Development Scientist to join a team in Cambridge, MA. This contract role involves applying advanced scientific principles to solve complex pharmaceutical development challenges and advance innovative therapies.

Responsibilities

• Develop, qualify, and transfer GC, HPLC, UPLC, and mass spectrometry-based assays for starting materials, raw materials, intermediates, and excipients to suppliers, CMOs, and QC teams.
• Identify impurity profiles and provide data to establish impurity limits.
• Apply advanced scientific principles, theories, and practices to process and analytical development.
• Author and review method development and qualification reports, SOPs, and transfer/qualification protocols and reports related to critical materials.
• Provide analytical support to internal teams and external partners.

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 both gas and liquid phases.
• Hands-on experience with method development and optimization using HPLC, UPLC, and GC for molecule and isomer separation.
• Solid background in organic chemistry with a focus on structure characterization and elucidation using mass spectrometry and NMR data.
• Familiarity with Waters and Agilent UHPLC and Mass Spectrometry hardware.
• Experience with software such as Empower, MassLynx, MassHunter, and Xcalibur CDS is preferred.
• Knowledge of peptide and/or oligonucleotide analysis is a plus.