Job Description

Job Description: Summary

The Associate scientist role within the Microscopy and Spectroscopy Lab (MSL) team in Manufacturing Sciences and Technology (MS&T) group will be 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 will also have responsibilities for investigating defective materials including but not limited to filters, single-use bioprocess containers, tubing, and polymeric fittings.

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.
• GMP regulations, investigations (particulate and foreign matter).
• "Bench" experience in forensics investigational work or analytical chemistry preferred.
• Excellent scientific, analytical, and troubleshooting skills
• Experience with the use of Scientific Software including Spectral data processing, hypercube spectral imaging, and MS Word, PowerPoint, and Excel.
• Has high level of initiative, requires minimal direction/oversight.
• Knowledge of cGMPs, compendial and FDA regulations.

Education:

• Required bachelor’s in forensic science degree, preferred master’s degree, or related field with at least 5 years of experience
• Experience using analytical instrumentation (FTIR, SEM/EDX, MicroProducts)

Duties:

• Microanalytical investigations involving the physical and chemical characterization and identification of materials related cell therapy products. This includes characterization of unknown components or foreign matter, and/or the specialized analysis of reagents, starting materials, single-use consumables, process intermediates, and drug products.
• Supporting day to day activities in the Microscopy and Spectroscopy lab including but not limited to, replenishment of lab supplies, analysis request distribution, interfacing with Facilities and EHS.
• Application of a wide variety of analytical testing techniques such as, microscopy and spectroscopy techniques including, UV/Vis, FT-IR, Raman, NIR, SEM/EDX, particle sizing and counting, and wet chemistry.
• Application 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 improvement or investigation projects.
• Perform laboratory work to support defective material and foreign matter assessments
• Perform analytical troubleshooting to solve manufacturing-related problems.

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