Analytical Services Chemist

Quality Seymour, Indiana


Description

Job Summary:
Primary responsibilities include testing and data compilation for raw material evaluations, method validation activities, USP monograph evaluations, equivalency testing of alternate materials, peer review of laboratory notebooks, assisting with laboratory investigations, and document review. This position is also responsible for the timely and accurate analysis of in-process, release and stability samples from the Technical Services department during the investigation of, or revisions to, manufacturing processes associated with commercial products.

Essential Functions:
• Analytical method development and validation for raw materials, in-process materials, and finished products
• Analytical method transfer with QC and with external customers
• Write validation and transfer protocols
• Write analytical methods
• Provide well-written, accurate and timely reports
• Perform accurate and timely analysis
• Perform all work using appropriate safety measures
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Accurate and timely analysis of Technical Services samples
• Peer review of data, reports and notebooks
• Assist in maintaining laboratory equipment and facilities

Training or Experience:
• Minimum of 3 years of experience with and application of CGMPs, USP/NF, FDA Guidelines and ICH Guidelines within the pharmaceutical industry
• Excellent oral and written communication skills
• Able to develop, troubleshoot, and validate analytical methods
• Able to troubleshoot laboratory instrumentation
• Working knowledge of Microsoft Word and Excel
• Strong experience with HPLC, GC, and Chromatography Data Acquisition systems
• Demonstrated ability to work as part of a cross-functional team
• Experience with particle size by laser diffraction, ICP-MS, mass spectroscopy, and/or dissolution analysis is a plus.

Education:
Degree in Chemistry or related field or applicable experience

Supervises/Manages:
• None