Associate Scientist

Job Description

Job 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.

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.

Education:

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

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.