Analytical Scientist

Job Title: Analytical Scientist – Solid Oral Product Development

Summary

The Analytical Development Department is dedicated to the successful and timely development of new pharmaceutical solid oral products by providing essential analytical development services to clients. The Analytical Scientist will offer analytical support for the team, contributing to the evaluation, development, and validation of analytical methods with limited supervision. The role also involves conducting routine analyses of active pharmaceutical ingredients (APIs) and finished products using advanced laboratory techniques and instrumentation.

Specific Duties, Activities, and Responsibilities

• Perform hands-on method development, improvement, and validation using techniques including, but not limited to: HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, and Particle Size Distribution (PSD).
• Assist in complex analytical experiments such as unknown impurity identification and excipient compatibility studies.
• Effectively prioritize activities to provide timely analytical support to product development initiatives.
• Anticipate analytical challenges in the R&D development process and provide strategic long-term planning for method development and enhancement.
• Support formulation development and technology transfer activities for assigned projects.
• Investigate method performance and reliability, and conduct optimization studies as necessary.
• Collaborate in the preparation of technical documents, including validation protocols and reports, stability protocols and reports, and analytical test procedures.

Education and Experience

• Bachelor’s degree (BS) in Chemistry, Biochemistry, or a related discipline with 6–8 years of pharmaceutical industry experience, or
• Master’s degree (MS) in Chemistry, Biochemistry, or a related discipline with 4+ years of pharmaceutical industry experience.

Knowledge/Skills

• Solid working knowledge of GxP principles, regulatory (ICH) guidelines, and compendial (USP/EP/JP) requirements for generic product development.