Summary Of Position

The Method Development and Analytical Services (MDAS) Research Associate I is a technical resource performing the analytical testing necessary to support development and commercialization of new pharmaceutical products. The Research Associate is responsible for performing the bench chemistry testing for release, stability and product characterization. They will perform laboratory work independently commensurate with training and experience.

Responsibilities

• Performs hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but not limited to performing assay, related compounds testing, dissolution, uniformity, and other tests to characterize and demonstrate product performance.
• Perform laboratory bench work to develop, optimize, and troubleshoot analytical methods for testing raw materials and products (semi-finished and finished) under the guidance of senior staff.
• Perform laboratory work for method validation/verification/transfer, equipment maintenance and calibration, reference standards qualification, drafting methods/reports, training, and other work as required under the guidance of senior staff.
• Conducts laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, GC, dissolution, UV-visible spectrophotometry, Karl Fischer, and other techniques as required.
• Provides training and guidance to junior staff on specific techniques as directed by management and specified training plans.
• Processes sample data to determine reported result. Ensure results are reported appropriately in designated computerized systems and/or directly to stakeholders.
• Evaluates data to ensure conformance with specifications, expectations, and trends. Identifies and investigates unexpected results.
• Peer review experimental documentation, calculations, and results generated by other staff for conformance with established procedures and scientific integrity.

Qualifications

• BS in Chemistry or related science plus 2 years experience in a pharmaceutical analytical laboratory.
• Familiar with GMP concepts related to pharmaceutical quality control
• Practical hands-on experience with the majority of the following: HPLC, GC, UV-Vis spectroscopy, dissolution, Karl Fischer, titration, FTIR, wet chemistry and USP/EP compendial test procedures.

We are willing to support relocation for any candidates who do not already live in the area.

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