Senior Scientist, Analytical Research & Development

Hikma Pharmacueticals USA, Inc. - Columbus, OH

Full-time - Mid Level

Columbus, OH

About the position

The Senior Scientist in Analytical Research & Development at Hikma Pharmaceuticals USA, Inc. is responsible for conducting analytical activities to support the development of manufacturable multisource pharmaceutical products. This role involves testing, analytical method development, validation, and ensuring compliance with regulatory standards. The scientist will analyze experimental data, troubleshoot analytical issues, and suggest process improvements to enhance efficiency in laboratory operations.

Responsibilities

• Conduct analytical activities in support of the development of a manufacturable multisource pharmaceutical product.
• Perform testing, analytical method development, and validation for regulatory submissions and product launch activities.
• Participate in method transfer activities and apply scientific principles and technologies.
• Analyze and interpret experimental data from laboratory work.
• Identify and implement contingency plans to prevent and overcome analytical issues.
• Support and suggest process improvements to refine current systems and improve efficiency.
• Review and check analytical data generated by peers to maintain data integrity.
• Support activities to maintain laboratory compliance with FDA/regulatory standards.
• Interface with enabling service teams regarding support needs and compliance.
• Ensure that all technical and safety training is current.

Requirements

• Bachelor's degree in chemistry, pharmaceutical sciences, or a related scientific discipline, or equivalent, with five years of progressive post-baccalaureate pharmaceutical experience in development and validation of wet analytical methods for drug substances and drug products.
• Experience using analytical instrumentation including HPLC (UV, RI and MS detection), GC, and ICP-MS.
• Experience in analyzing APIs with techniques like wet particle size distribution analysis using a Malvern particle size analyzer.
• Familiarity with relevant FDA guidance documents.
• Alternatively, a master's degree in chemistry, pharmaceutical sciences, or a related scientific discipline, or equivalent, with three years of pharmaceutical experience in similar areas.