Process Engineering Scientist

Job Description

Job Summary:

• Responsible for supporting pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

Duties and Responsibilities:

• Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
• Design and run experiments.
• Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.
• Complete, analyze and present data analysis.
• Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports.
• Supports validation efforts in the development of validation strategies and testing plans
• Provide input into process related investigations and complete MST investigations as required.
• Advise on root-cause analysis of undesired trends or deviations related to process equipment.
• Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed
• Support the Change Control process.
• Position does handle hazardous material.

Education, Experience and Skills:

• Bachelor’s Degree in a Science Related field required.
• Experience working in or supporting pharmaceutical operations required–minimum of 4 years.
• 6+ years of DP technical experience, support during experimental phase and process validation and the Pharma space for oral solids.
• Experience writing OSD strategies, study plans, study reports, validation protocols and reports.
• 4+ years of expertise in data evaluation, managing Risk Assessments.
• 5+ years of expertise working process related Investigations and change controls.
• Comfortable wearing proper PPE and working in a Laboratory — time in Laboratory will fluctuate.
• Strong communication skills, working with a team, and accountable for their work.