Engineering - Associate Scientist

Summary

The Associate Scientist role will investigate physical and chemical characterization and identification of materials used in cell therapy product manufacturing, including unknown components or foreign matter, and defective materials like filters, single-use bioprocess containers, tubing, and polymeric fittings.

Requirements

• Broad based experience in analytical and pharmaceutical chemistry with hands-on exposure to advanced analytical technology.
• Experience with spectroscopic techniques including Raman, Mid-IR, Mass spectrometry, and others for protein identification and characterization.
• Knowledge of protein / cell chemistry related to structure and function is a plus.
• GMP regulations, investigations (particulate and foreign matter).
• Bench experience in forensic investigative work or analytical chemistry preferred.
• Excellent scientific, analytical, and troubleshooting skills.
• Experience with scientific software including spectral data processing, hypercube spectral imaging, and MS Word, PowerPoint, and Excel.
• High level of initiative, minimal direction/oversight required.
• Knowledge of cGMPs, compendia, and FDA regulations.

Duties

• Microanalytical investigations involving the physical and chemical characterization and identification of materials related to cell therapy products.
• Supporting day-to-day activities in the Microscopy and Spectroscopy lab, including replenishing lab supplies, distributing analysis requests, interfacing with Facilities and EHS.
• Application of various analytical testing techniques such as microscopy, spectroscopy, UV/Vis, FT-IR, Raman, NIR, SEM/EDX, particle sizing and counting, and wet chemistry.
• Use of spectroscopic techniques to identify and characterize cell-therapy based drug products and intermediates.
• Provide timely and efficient technical support.
• Write comprehensive technical reports to document all analytical improvements or investigation projects.
• Perform laboratory work to support defective material and foreign matter assessments.
• Perform analytical troubleshooting to solve manufacturing-related problems.