About the position
The position involves designing, executing, and analyzing studies to develop and qualify test methods, demonstrating technological feasibility, and characterizing material and assembled device products. This includes employing multiple analytical methods such as FTIR, DSC, TGA, and various mechanical tests. The role also requires enabling the transfer of assays to Quality Control (QC) and providing subject matter expertise (SME) to support assay qualification. Responsibilities include executing test methods in support of device process development and quality activities, troubleshooting and optimizing assay and process performance, and managing third-party vendors or Contract Research Organizations (CROs). The position also involves reporting on project progress, writing analytical development protocols and reports, and ensuring compliance with regulatory standards.
Responsibilities
- Design, execute and analyze studies to develop and qualify test methods.
- Demonstrate technological feasibility and characterize material and assembled device products.
- Employ multiple analytical methods including FTIR, DSC, TGA, and mechanical tests.
- Enable transfer of assays to QC and provide SME support for assay qualification.
- Execute test methods in support of device Process Development and Quality activities.
- Troubleshoot, optimize, and trend assay and process performance.
- Manage third-party vendors/CROs.
- Report on project progress and write analytical development protocols and reports.
- Identify, qualify, and manage analytical reagents as per regulatory standards.
- Establish design criteria using Design of Experiments (DOE) and perform statistical analysis.
- Establish reference standard materials to support assay validation.
- Contribute to regulatory submission documents with detailed method descriptions and data analysis.
- Ensure the accuracy and integrity of analytical data generated.
- Maintain excellent written documentation and review lab notebooks and test forms.
Requirements
- Bachelor's degree (or equivalent degree) and 2-4 years of experience in analytical development program or other analytical support function, or Master's degree (or equivalent degree) and 1-2 years of experience.
- Knowledge and hands-on experience with analytical platforms used for characterization and release assays.
- Knowledge of at least two of the following methods: FTIR, DSC, TGA, mechanical tests for hardness, viscosity, chromatography, particle size, NGI, autoinjector and pre-filled syringes, and material stress/strain characteristics.
- Experience in development and validation of analytical methods.
- Strong communication skills for collaboration across teams.
- Experience with sample management and electronic documentation systems in the GMP environment.
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