Position Summary

The Chemist II will perform analytical testing to support ongoing product release, raw material release and stability studies as needed, generate, and review technical documents that support raw material and product release and stability under minimal supervision, and will be responsible for managing their activities with good time management to maximize productivity. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

Job Responsibilities

• Perform analytical testing of samples supporting incoming raw materials, in-process production, drug product and stability samples with some supervision
• Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, ICP and wet chemistry techniques, UV/VIS, KF, and Polarimeter, etc.
• Perform instrument troubleshooting and preventive maintenance with guidance from laboratory leadership as needed
• Perform calibrations and calibration verifications
• Compile data to support trending analysis
• Write, review, and update standard operating procedures and department policies as needed
• Draft and review technical documents supporting raw material and/or drug product release and stability with some supervision
• Perform all activities in compliance with cGLP/cGMP requirements
• Assume other responsibilities as assigned by area management
• Perform other duties as assigned

• Ability to perform troubleshooting with instrumentation
• Perform testing with minimal oversight and guidance
• May handle hazardous waste as required to dispose of laboratory solutions. Basic RCRA training is required for all employees of the laboratory and continuing RCRA training will be performed on an annual basis. New hires may only handle hazardous waste prior to attending RCRA training if they are under the supervision of a RCRA trained employee. RCRA training will be attended within six (6) months of hire.

Experience Requirements

• Experience with particulate identification is a plus
• Must have good verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skills
• Experience with Empower
• Experience with Chromatography
• USP and EP experience

Education Requirements

• Bachelor's degree in chemistry or related scientific discipline with 3+ years of relevant laboratory experience; or an associate's degree with approximately 5+ years of relevant industry experience