Particle Characterization Scientist

The Particle Characterization Scientist operates independently to perform particle characterization of raw materials and finished The ideal candidate will have expertise in advanced particle analysis techniques and instrumentation as well as being familiar with key particle characterization deliveries such as method development.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Subject matter expert in wide range of analytical techniques to characterize particles in sterile drug products
• · Operate and maintain particle analysis instrumentation
• · Analyze and interpret complex data
• · Develop and optimize particle characterization methodologies.
• · Carry out all aspects of particle work in the laboratory and execute experiments in a safe manner
• · Accurate and timely recording of experiments, data, and findings.
• · Present your work clearly and concisely to stakeholders, both internally and externally through written and verbal communications
• · Work in cross functional teams as necessary to complete projects, improve processes to reduce particle introduction into the manufacturing process
• · Perform daily calibrations and necessary preventative maintenance on specified analytical equipment.
• · Multitask projects while maintaining efficient and accurate laboratory practices.
• · Accurately documents all necessary and relevant information in a clear and concise manner per cGMP requirements.
• · Ability to create and execute both method protocols and reports.
• · Lead and oversee the development of pharmaceutical products using advanced particle characterization techniques to support GMP quality investigations

QUALIFICATIONS

• Bachelor’s degree in chemistry, engineering, pharmaceutical sciences, or material sciences 5+ years of pharmaceutical experience working in sterile injectable facility supporting particle analysis in raw materials and finished goods
• Understanding Of Regulatory Guidelines And Requirements For Pharmaceutical Products, Including Relevant ICH, FDA, And EMA Guidelines.
• Capable of wearing all appropriate PPEs correctly during handling of hazardous substances
• Some work may require extended periods of time standing at a lab bench
• Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)
• Must be able to lift up to 15 pounds at times.