Engineering - Associate Scientist

About the role

This position is responsible for investigations involving the physical and chemical characterization and identification of materials such as unknown components or foreign matter in manufacturing processes for cell therapy products. The role also includes responsibilities for investigating defective materials including but not limited to filters, single-use bioprocess containers, tubing, and polymeric fittings.

Responsibilities

• Microanalytical investigations involving the physical and chemical characterization and identification of materials related to cell therapy products, including characterization of unknown components or foreign matter, and/or the specialized analysis of reagents, starting materials, single-use consumables, process intermediates, and drug products.
• Support day-to-day activities in the Microscopy and Spectroscopy lab, including replenishment of lab supplies, analysis request distribution, and interfacing with Facilities and EHS.
• Apply a wide variety of analytical testing techniques such as microscopy and spectroscopy (UV/Vis, FT-IR, Raman, NIR, SEM/EDX), particle sizing and counting, and wet chemistry.
• Apply 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 improvement or investigation projects.
• Perform laboratory work to support defective material and foreign matter assessments.
• Perform analytical troubleshooting to solve manufacturing-related problems.

Requirements

• Broad-based experience in an area relevant to analytical and pharmaceutical chemistry with hands-on exposure to state-of-the-art analytical technology, such as microscopy, spectroscopy, FT-IR, confocal Raman, SEM/EDX, UV Vis, and NIR.
• Experience utilizing spectroscopic techniques including Raman, Mid-IR, Mass spectrometry, and others for protein identification and characterization is highly desirable.
• Knowledge of protein/cell chemistry related to structure and function is a plus.
• Familiarity with GMP regulations and investigations (particulate and foreign matter).
• "Bench" experience in forensics investigational 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; requires minimal direction/oversight.
• Knowledge of cGMPs, compendial, and FDA regulations.

Qualifications

• Master’s in Chemistry, Material Science, Chemical Engineering, or related field with at least 2 years of experience.
• Bachelor’s in Chemistry, Material Science, Chemical Engineering, or related field with at least 5 years of experience.
• Experience using analytical instrumentation (FTIR, SEM/EDX, Microscopes).