at Actalent in Round Lake, Illinois, United States
Job Description
Description:
Department/Function: Pharmaceuticals R&D New Product Development/Stability Summary: This position is responsible for analytical testing, validation/verification, and/or transfer of test method supporting Pharmaceuticals parenteral products. Work will primarily support new product development and sustaining product initiatives. The individual in this position must: * Effectively contribute solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance. * Display basic technical understanding of related disciplines. * Conduct routine/non-routine research and design experiments with minimal assistance Essential Duties and Responsibilities: * Conduct critical chemical, and physical analyses on finished product stability samples. May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or department projects. Work under minimum supervision. * Perform review of test data, which includes overall documentation practices. * Use sophisticated laboratory instrumentation and computer systems to collect and record data (LCMS system). * Perform advanced chemical assays requiring precise analytical skills and understanding of chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules * Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations. * Investigate deviations and write exception documents. * Collaborate with other functions/departments to solve problems, increase efficiency, improve quality and provide product support. * Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot basic instrument problems Qualifications: * Must have good oral and written communication skills, strong analytical skills and be detail oriented. * Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis * Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion * Must be able to handle multiple tasks concurrently and in a timely fashion * Possess writing and computer skills * Must communicate effectively with managers, peers, and subordinates. * Interpret available information and make recommendation to resolve technical challenges Physical Activities and Requirements: * Must be able to hand write and use computers for the majority of the work day * Must be able to transfer materials, mix solutions/product(s), open products, and perform laboratory testing * May require standing for extended periods * Must be able to lift up to 10 pounds routinely * This work is subject to hazards including exposure to chemicals, drug products. Education and/or Experience: * Bachelors degree in relevant scientific discipline (e.g. chemistry, pharmaceutical sciences) with analytical chemistry laboratory coursework and at least 2-5 years of experience or advanced degree in Chemistry * Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, Mass Spectrometry) * Pharmaceutical GMP laboratory experience is desired * Residue analysis experience by LC-MS/MS is desired
Skills:
LAB, chemistry, GC, HPLC, LCMS, FDA, GMP
Top Skills Details:
LAB,chemistry,GC
Additional Skills & Qualifications:
HPLC LCMS FDA/GMP
Experience Level:
Intermediate Level
About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
