Scientist I

Job Description

Duties and Responsibilities:

• Support planning and execution of equipment qualification and process validation activities.
• Execute validation studies supporting bead and resin manufacturing process improvements and capacity expansion.
• Develop and execute validation protocols and experimental plans with guidance from Manufacturing Sciences project leads.
  Perform hands-on laboratory and manufacturing-floor activities associated with equipment and process
• validation.
• Collect, organize, and analyze experimental and manufacturing data using appropriate statistical methods.
• Prepare validation protocols, reports, technical summaries, and other supporting documentation.
• Partner with Operations and Engineering to troubleshoot equipment and manufacturing process issues identified during validation and implementation.
• Support process characterization, optimization, and continuous improvement activities for desalting resin manufacturing.
• Assist with implementation of validated processes and equipment into routine manufacturing.
• Ensure documentation complies with applicable SOPs, quality systems, and internal requirements.
• Communicate project status, experimental results, risks, and recommendations to Manufacturing Sciences and cross-functional stakeholders.
• Support additional Manufacturing Sciences validation and manufacturing troubleshooting activities as project priorities require.

Education and Experience:

• Bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related scientific/engineering discipline.
• 2 years of relevant laboratory, manufacturing, process development, or validation experience.
• Experience planning and executing laboratory or manufacturing experiments with limited guidance.
• Experience with equipment qualification, process validation, or manufacturing process improvement.
• Experience working with manufacturing equipment and supporting equipment/process implementation.
• Experience with statistical analysis software such as Minitab, JMP, or Design Expert.
• Experience in regulated manufacturing environments and familiarity with ISO/GMP quality systems.
• Experience with chromatography, bead and resin manufacturing, bioprocessing, or related manufacturing processes.
• Experience with root cause analysis, process troubleshooting, and continuous improvement methodologies.

Knowledge, Skills, and Abilities:

• Familiarity with validation lifecycle documentation, including protocols, data analysis, and final reports.
• Strong technical documentation and data analysis skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint.
• Ability to work effectively in a hands-on manufacturing environment and collaborate with cross-functional teams.
• Strong analytical, troubleshooting, organizational, and communication skills.