Method Validation & Transfer Scientist

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Job description

Job Description

Position Overview:

The resource will work at a client facility in Sanford, NC and will be a member of the Quality Control Portfolio Management team to support multiple quality programs. The resource will be able to analyze chemical, or biological or microbiological products. The resource should be able to perform the analytical or chemical or microbial and sterility testing in the GMP laboratory setting and should be able to collaborate efficiently with the external teams. Additionally, the candidate should be able to document all the data to in accordance with cGMP and data integrity principles. The resource should be able to review the validation data as a second analyst reviewer.

Position Responsibilities:

Independently plan and execute laboratory experiments.

Collaborate with trainers, colleagues and subject matter experts to perform the assays in the laboratories, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.

Assisting teams in completing the assays required for the validation and transfer of methods.

Engage with the method development team and participate in both in-process and final product sample analyses.

Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.

Prepare technical reports, critically review data as second analyst for the validations, and evaluate new instrumentation and analytical techniques as required.

Independently analyze experimental data and provide conclusive insights.

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