Our client, a leading pharmaceutical company, is hiring Process Engineering, Scientist on a contract basis.
Job ID: 83568
Work Location:
New Brunswick, NJ (Hybrid Working Model)
Summary 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 assessments, 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
Required Qualifications:
- 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, 4+ years of expertise managing Risk Assessments
- 5+ years of expertise working process related Investigations and change controls.
- Bachelor’s Degree in a Science Related field required
- Experience working in or supporting pharmaceutical operations required–minimum of 4 years
- Comfortably 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
Pay Rate: $65- $75/hour W2