Research Associate Scientific II
25212 W IL Route 120 Round Lk Bch, IL 60073 US
This position is responsible for analytical testing, validation/verification, and/or transfer of test method supporting Pharmaceuticals parenteral products. Work will primarily support stability testing, but may also support new product development and/or 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
The individual must not be allergic to Penicillin, Cephalosporin, or their related products and/or materials.
Essential Duties and Responsibilities:
- Conduct critical chemical, physical, and biological 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. Perform review functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to be a system owner or conduct validations.
- Perform advanced biological and 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
- 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, and bacteria. This includes Penicillin, Cephalosporin, their related products and/or materials
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 or Biological Sciences
- Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, GC, pH, KF, TOC, AA, GFAA, titration, etc.)
- Pharmaceutical GMP laboratory experience is desired
- Stability study execution and validation experience is desired
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.