Sr. Scientist I - Mass Spec

Responsibilities

• Uses advanced skills in multiple techniques: HPLC, LC/MS and GC/MS assays for residual solvents, nitrosamines, genotoxic impurities, identification and characterization of unknown impurities.
• Develops analytical methodology for analysis via HPLC, LC/MS and GC/MS.
• Performs quantitative and qualitative mass spectrometry work using specific instrument types (i.e. triple quadrupole and QTOF systems).
• Performs GMP review of solutions and chromatography.
• Develops and validates methods, test procedures, protocols, and reports.
• Understands the theoretical basis of methods/experiments.
• Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Analyzes information for technical correctness and accuracy.
• Evaluates and interprets data.
• Drives initiatives outside of standard work function.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Chemistry with 8+ years of experience, or Master’s degree with 4+ years of experience, or Ph.D. with 2+ years of experience required.
• 2+ years of experience cGMP in a pharmaceutical or regulated environment required.
• CDMO experience is preferred.
• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Ability to develop and implement new methods/processes required.
• Mass spectrometry (GC/MS, LC/MS, triple quadrupole, QTOF) skills and quantitative/qualitative work experience required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.