Job Description:

• Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and company policies and procedures.

Primary Responsibilities

• Perform routine testing (dissolution, assay/degradant, content uniformity and ID) of drug products in a cGMP laboratory.
• Complete all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Enter data into laboratory information system and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures; perform basic troubleshooting.
• Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
• Aid other group members as required.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in analysis.
• Performs other related assignments and duties as required and assigned.

Education and Experience Requirements:

• The incumbent must have a BA or BS degree in Chemistry or closely related science. Minimum of 1-year relevant experience preferred.

Necessary Knowledge, Skills, and Abilities:

• Understanding of analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE).
• Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.