at DivIHN Integration, Inc in Hoffman Estates, Illinois, United States
Job Description
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Divya | 224 369-2969
Rakesh | 630 847 0275
Title: Research Associate Scientific II
Location: Round Lake, IL
Duration: 12 Months
Summary: 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
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, 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.
