Job description
Research Associate, Material Sciences
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Job Description
The Research Associate, Material Sciences is responsible for the generation of material risk assessments which include but not limited to raw materials and product contact component consumables. They will generate Bill of Materials that will be used to support clinical and commercial cGMP manufacturing processes. The will support business activities such as; supporting investigations pertaining to materials, supporting and managing supplier related changes and maintenance/archival of documents such as TSE/BSE and Nitrosamine assessments of procured materials.
Responsibilities:
- Perform material risk assessment; Provide Justification of Specifications for controlled materials.
- Coordinate with multiple functions (including QA, QC, Procurement, Process Development, and Manufacturing) on material risk assessment and defining Material Specifications.
- Generate Bill of Materials (BOMs) for clinical and commercial production.
- Maintain and archive product contact component extractables/leachables (E/L) risk assessment reports, TSE/BSE, Nitrosamine assessments on procured materials. Collect and archive vendor/ material information and assessment results.
- Manage and archive Supplier Change Notifications processed by the Material Sciences Department. Communicate to relevant teams on impact of Change Notifications.
- Support Manufacturing on material sciences related investigations
Qualifications
Required:
- Bachelor’s degree in Chemistry, Life Sciences, Biotechnology or related field of study.
- At least 1 internship experience in cGMP biopharmaceutical environment.
Preferred Skills:
- Experience in supporting cross-functional activities.
- Interdisciplinary project management skills.
- Knowledge of manufacturing processes, regulatory requirements, risks associated with raw materials for pharmaceuticals.
- Active participation in collaborative cross-functional team. Proficient at developing collaborative relationships between supplier and user.
- Excellent verbal and written communication skills, and interpersonal skills.
- Strong organizational skills and attention to details. Excellent time management skills.
- Ability to function well in a high-paced environment, Self-starter.
- Proficient with Microsoft Office Suite or related software.
Function
Sub Function
Reports To
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