Chemist II

Exela Pharma Sciences•Lenoir, NC

16h

About The Position

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.

Requirements

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

Nice To Haves

Experience with particulate identification is a plus

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.