Description

You will own analytical method development, validation, and transfer for pharmaceutical solid oral products. You execute hands-on testing and documentation while supporting formulation and R&D timelines.

Responsibilities

• Execute method development, improvement, and validation using HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, and PSD.
• Perform routine analysis of APIs, excipients, and finished products using laboratory instrumentation.
• Conduct complex experiments including unknown impurity identification and excipient compatibility studies.
• Prepare technical documentation, including validation protocols, reports, reference standard qualification reports, and analytical test procedures.
• Support formulation development, transfer activities, and investigations into method performance and reliability.

Required Skills

• Hands-on experience with HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, and PSD.
• Working knowledge of GxP, ICH regulatory requirements, and compendial standards (USP/EP/JP).
• Proficiency in Microsoft Office, specifically Excel and PowerPoint.
• Strong technical documentation and data management skills.
• Ability to prioritize activities to meet R&D development timelines.
• Bachelor's Degree in Chemistry, Biochemistry, or a related discipline with 4+ years of pharmaceutical industry experience, or a Master's Degree with 2+ years of experience.

Preferred Skills

• Prior experience specifically in Analytical R&D.

Key Skills

Education

Bachelor's Degree